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Notice

Medical Devices; Exemptions From Premarket Notification: Class II Devices

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Information about this document as published in the Federal Register.

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: Gregory.Bennett@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 14, 2017 (82 FR 13609), FDA issued a notice proposing to exempt a list of class II devices from the premarket notification requirements under section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)), subject to certain limitations. This notice was issued in accordance with the 21st Century Cures Act (Pub. L. 114-255), which was signed into law on December 13, 2016. Section 3054 of that statute amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act provides that, within 90 days after enactment of the 21st Century Cures Act and at least once every 5 years thereafter, FDA must publish in the Federal Register a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act (generally referred to as a premarket notification or “510(k)”) to provide reasonable assurance of safety and effectiveness. Within 210 days of enactment of the 21st Century Cures Act, FDA must publish in the Federal Register a list representing its final determination regarding the list of devices proposed in the March 14, 2017, notice. Section 510(m)(3) of the FD&C Act provides that upon the date that this final list is published in the Federal Register, a 510(k) will no longer be required for the listed devices and the applicable classification regulation for these devices shall be deemed amended to incorporate such exemption. Interested persons were given until May 15, 2017, to comment on the proposed list of class II devices. After reviewing these comments and considering whether the proposed list should be modified, FDA is now identifying its final determination as to which of those devices are now exempt from premarket notification requirements, subject to certain limitations, as indicated in tables 1 to 3 of this notice.

In a future action, FDA intends to amend the codified language for each listed device's classification regulation to reflect this final determination. Persons with pending 510(k) submissions for devices that are now exempt from premarket notification, subject to the limitations on exemptions, should withdraw their submissions.

These exemptions will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. Specifically, regulated industry will no longer have to invest time and resources in premarket notifications, including preparation of documents and data for submission to FDA, payment of user fees associated with 510(k) submissions, and responding to questions and requests for additional information from FDA during 510(k) review.

II. Criteria for Exemption

There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, Federal Register notice (63 FR 3142) and subsequently in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (“Class II 510(k) Exemption Guidance”) (Ref. 1).Start Printed Page 31977

III. Limitations on Exemptions

FDA believes that the types of class II devices listed in this notice should be exempt from the premarket notification requirements found under section 510(k) of the FD&C Act. However, an exemption from the requirement of premarket notification does not mean that the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness for devices listed in this document is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide.

In addition to being subject to the general limitations to the exemptions found in Title 21 of the Code of Federal Regulations (CFR) sections 862.9 to 892.9 (§§ 862.9 to 892.9), when Agency assessment determines that the factors laid out in the Class II 510(k) Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all devices in a particular group, FDA may partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. Partial exemption limitations can be found in table 2 of this notice. FDA has assigned new product codes to the device types that are now exempt subject to the partial limitations in order to ensure that these devices can be separated from devices that do not fall within the partial exemption limitation under the existing product code (i.e., exempt and non-exempt devices within a device type will have distinct product codes). If table 2 indicates that a partial exemption limitation does apply to a device, then affected device manufacturers should review their registration and listing information to assess if they should list their device using the original classification product code, which requires premarket notification, or the new classification product code for the subset of that device type that is now 510(k) exempt (subject to the general limitations to the exemptions found in §§ 862.9 to 892.9). In table 2, for example, FDA is listing the exemption of the tympanometer but limits the exemption to such devices that are in compliance with FDA-recognized consensus standard ANSI S3.39. Tympanometers that comply with this partial exemption limitation and the corresponding general limitations in § 874.9 are now exempt from the 510(k) requirements and should be identified under new product code “PTP” in subsequent registration and listing submissions. However, tympanometers not in compliance with each of these exemption limitations remain subject to the 510(k) requirements and will retain product code “NAS.” We recommend that device manufacturers document in their records any changes in the product code of their device with appropriate justification.

IV. List of Class II Devices

In table 1, FDA is identifying the following list of class II devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9:

Table 1—Class II Devices

21 CFR sectionDevice typeProduct code
862.1020Acid Phosphatase, NitrophenylphosphateCJN
862.1020Acid Phosphatase, Thymol Blue MonophosphateCJR
862.1020Acid Phosphatase, Disodium PhenylphosphateCJX
862.1020Acid Phosphatase, Naphthyl PhosphateCKB
862.1020Acid Phosphatase, Thymolphthale InmonophosphateCKE
862.1020Acid Phosphatase, Beta GlycerophosphateCKH
862.1020Acid Phosphatase (Prostatic), Tartrate InhibitedJFH
862.1090Radioassay, Angiotensin Converting EnzymeKQN
862.1100Vanillin Pyruvate, AST/SGOTCIF
862.1100Diazo, AST/SGOTCIQ
862.1100Hydrazone Colorimetry, AST/SGOTCIS
862.1100NADH Oxidation/NAD Reduction, AST/SGOTCIT
862.1150Calibrator, PrimaryJIS
862.1150Calibrator, SecondaryJIT
862.1150Calibrator, SurrogateJIW
862.1150Calibrator, Multi-Analyte MixtureJIX
862.1345Drink, Glucose ToleranceMRV
862.1350Continuous Glucose Monitor Secondary DisplayPJT
862.1445Chromatographic Separation, Lactate Dehydrogenase IsoenzymesCEX
862.1445Electrophoretic, Lactate Dehydrogenase IsoenzymesCFE
862.1445Differential Rate Kinetic Method, Lactate Dehydrogenase IsoenzymesJGF
862.1509System, Test, Urinary Methylmalonic AcidLPT
862.1685Radioimmunoassay, Thyroxine-Binding GlobulinCEE
862.1700Radioimmunoassay, Total ThyroxineCDX
862.1700Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI
862.2265High Throughput DNA Sequence AnalyzerPFF
862.2570Instrumentation For Clinical Multiplex Test SystemsNSU
862.2570Real Time Nucleic Acid Amplification SystemOOI
862.2570Mass Spectrometer For Clinical Multiplex Test SystemsOTA
862.2570Micro Total Analysis Instrument SystemOUE
862.2570Complete Gene Expression Profiling Accessory ReagentsOVA
862.2570DNA Genetic AnalyzerPCA
862.2570Data Acquisition SoftwarePQQ
862.3200Calibrators, Drug MixtureDKB
862.3200Calibrators, Drug SpecificDLJ
Start Printed Page 31978
862.3200Calibrators, Ethyl AlcoholDNN
864.5400FibrometerGIE
864.5400Timer, CoagulationJBT
864.5425Control, Plasma, AbnormalGGC
864.5425Plasma, Coagulation ControlGGN
864.5425Plasma, Control, NormalGIZ
864.6550Control, Fecal Occult BloodOSL
864.6650Study, Platelet AdhesiveJBZ
864.7275Test, Euglobulin LysisJBO
864.7300Fibrin Monomer ParacoagulationJBN
864.7340Fibrinogen StandardGFX
864.7340Plasma, Fibrinogen ControlGIL
864.7375Glutathione, Red-CellGII
864.7375Fluorescence, Visual Observation (Qual., U.V.), Glutathione ReductaseJMH
864.7375Assay, Glutathione ReductaseKQF
864.7415Control, Hemoglobin, AbnormalJCM
864.7455Stain, Fetal HemoglobinGHQ
864.7500Acid HematinGGF
864.7720Test, Prothrombin ConsumptionGGQ
864.7735Prothrombin-Proconvertin and ThrombotestJPF
864.8150Calibrator for Cell IndicesKRX
864.8165Calibrator for Hemoglobin and Hematocrit MeasurementKRZ
864.8175Calibrator for Platelet CountingKRY
864.8185Calibrator for Red-Cell and White-Cell CountingKSA
864.8625Standards and Controls, Hemoglobin, Normal and AbnormalGFS
864.8625Control, White-CellGGL
864.8625Control, HemoglobinGGM
864.8625Control, PlateletGJP
864.8625Control, Red-CellGJR
864.8625Control, HematocritGLK
864.8625Mixture, Control, White-Cell and Red-Cell IndicesGLQ
864.8625Control, Cell Counter, Normal and AbnormalJCN
864.8625Mixture, Hematology Quality ControlJPK
864.8625Material, Quality Control, Semen AnalysisNRF
864.8625Control Material, Blood Circulating Epithelial Cancer CellNRS
864.9400Solution, Stabilized EnzymeKSK
866.3395Norovirus Serological ReagentsOUC
866.5210Immunochemical, CeruloplasminCHN
866.5210Ceruloplasmin, Rhodamine, Antigen, Antiserum, ControlDCT
866.5210Ceruloplasmin, FITC, Antigen, Antiserum, ControlDCY
866.5210Ceruloplasmin, Antigen, Antiserum, ControlDDB
866.5210P-Phenyl-Enediamine/EDTA (Spectrophotometric), CeruloplasminJFQ
866.5210Indirect Copper Assay, CeruloplasminJFR
866.5470Hemoglobin, Chain Specific, Antigen, Antiserum, ControlDAM
866.5620Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, ControlDDT
866.5620Alpha-2-Macroglobulin, FITC, Antigen, Antiserum, ControlDDY
866.5620Alpha-2-Macroglobulin, Antigen, Antiserum, ControlDEB
866.5630System, Test, Beta-2-Microglobulin ImmunologicalJZG
866.5910Quality Control Material, Genetics, DNANZB
868.1040Algesimeter, PoweredBSI
868.1400Legging, Compression, Non-InflatableLLK
868.2500Monitor, Oxygen, Cutaneous, For Infant Not Under Gas AnesthesiaKLK
868.2500Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas AnesthesiaLPP
868.2550PneumotachometerJAX
868.5180Bed, Rocking, Breathing AssistCCO
868.6250Compressor, Air, PortableBTI
870.1390TrocarDRC
870.1875Lung Sound MonitorOCR
870.2675OscillometerDRZ
870.4280Filter, Prebypass, Cardiopulmonary BypassKRJ
870.4290Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL
870.4340Monitor and/or Control, Level Sensing, Cardiopulmonary BypassDTW
870.4420Sucker, Cardiotomy Return, Cardiopulmonary BypassDTS
870.4430Suction Control, Intracardiac, Cardiopulmonary BypassDWD
872.1720Tester, PulpEAT
872.3260External Cleaning SolutionPME
872.3300Coating, Denture Hydrophilic, ResinEBE
872.3540Pad, Denture, Over The CounterEHR
872.3540Cushion, Denture, Over The CounterEHS
872.3560Reliner, Denture, Over The CounterEBP
872.3590Denture, Plastic, ToothELM
Start Printed Page 31979
872.3600Denture Preformed (Partially Prefabricated Denture)EKO
872.3890Splint, Endodontic StabilizingELS
872.5550Ring, Teething, Fluid-FilledKKO
872.6770Syringe, CartridgeEJI
874.1120Generator, Electronic Noise (for Audiometric Testing)ETS
874.1325ElectroglottographKLX
874.3310Calibrator, Hearing Aid/Earphone and Analysis SystemsETW
874.3320Hearing Aid, Group and Auditory TrainerEPF
874.3320Device, Assistive ListeningLZI
874.3330Hearing Aid, MasterKHL
874.3430Mold, Middle-EarETC
874.3730Device, Voice AmplificationMCK
876.1500Light Source, Incandescent, DiagnosticFCQ
876.1500Light Source, Photographic, FiberopticFCR
876.1500Light Source, Fiberoptic, RoutineFCW
876.1500Carrier, Sponge, EndoscopicFGS
876.1500Light Source, Endoscope, Xenon ArcGCT
876.1500Transformer, EndoscopeGCW
876.1500LED Light SourceNTN
876.1500Endoscopic Guide Wire, Gastroenterology-UrologyOCY
876.4020Light, Catheter, Fiberoptic, Glass, UreteralFCS
876.4270Rod, ColostomyEZP
876.4400Ligator, HemorrhoidalFHN
876.4400Ligator, EsophagealMND
876.4500Lithotriptor, Biliary MechanicalLQC
876.4770UrethrotomeEZO
876.5010Bag, Bile CollectingEXF
876.5025Vibrator for Climax Control of Premature EjaculationPIA
876.5365Dilator, Esophageal (Metal Olive) Gastro-UrologyEZM
876.5365Bougie, Esophageal, and Gastrointestinal, Gastro-UrologyFAT
876.5365Dilator, EsophagealKNQ
876.5520Dilator, UrethralKOE
876.5665Disinfectant, Subsystem, Water PurificationNIH
876.5820Set, Dialyzer HolderFKI
876.5895Irrigator, OstomyEXD
876.5980Catheter, Retention, Barium Enema With BagFGD
876.5980Gastrostomy Tube HolderPLI
878.4370Drape, Surgical, ENTERY
878.4370Drape, Pure Latex Sheet, With Self-Retaining Finger CotEYX
878.4370Drape, Urological, DisposableEYY
878.4370Pad, KellyFNW
878.4370Drape, Patient, OphthalmicHMT
878.4370Drape, Microscope, OphthalmicHMW
878.4370Ring (Wound Protector), Drape Retention, InternalKGW
878.4580Lamp, Operating-RoomFQP
878.4580Light, Surgical, InstrumentFSQ
878.4580Light, Surgical, Floor StandingFSS
878.4580Light, Surgical, EndoscopicFSW
878.4580Light, Surgical, ConnectorFSX
878.4580Light, Surgical, Ceiling MountedFSY
878.4580Light, Surgical, CarrierFSZ
878.4580Light, Surgical, AccessoriesFTA
878.4580Lamp, SurgicalFTD
878.4580Illuminator, RemoteFTG
878.4580Lamp, Surgical, IncandescentGBC
878.5070Apparatus, Air Handling, BenchFZG
878.5070Apparatus, Air Handling, RoomFZH
878.5070Apparatus, Air Handling, EnclosureFZI
880.5580Locator, Acupuncture PointBWJ
880.5580Needle, Acupuncture, Single UseMQX
880.5780Stocking, Medical Support (to Prevent Pooling of Blood in Legs)DWL
882.1020Analyzer, RigidityGZM
882.1540Device, Galvanic Skin Response MeasurementGZO
882.1560Device, Skin Potential MeasurementHCJ
882.1855Encephalogram Telemetry SystemGYE
882.5895Vibratory Counter-StimulationOVP
884.2990Sheet, Recording, Breast ExaminationNHM
884.3200Drain, CervicalHFL
884.4400Forceps, ObstetricalHDA
884.4530Clamp, UmbilicalHFW
884.4530Speculum, Vaginal, NonmetalHIB
Start Printed Page 31980
884.4530Speculum, Vaginal, Nonmetal, FiberopticHIC
884.4530Clamp and Cutter, UmbilicalNBZ
884.4900Table, Obstetrical, AC-Powered (and Accessories)HDD
884.4900Table, Obstetrical, Manual (and Accessories)HHP
884.4900Table, Obstetric (and Accessories)KNC
884.5200Hemorrhoid Prevention Pressure WedgeOOA
884.5390Heater, Perineal, Direct ContactHGZ
884.5390Heater, Perineal, Radiant, Non-ContactHHA
884.5390Heater, PerinealKND
884.5400Cup, MenstrualHHE
884.5425Pad, Menstrual, ScentedHHL
884.6150Micromanipulators and Microinjectors, Assisted ReproductionMQJ
886.1120PhotorefractorMMF
886.1120Camera, Ophthalmic, General-UsePJZ
886.1250Euthyscope, AC-PoweredHMK
886.1570Ophthalmoscope, AC-PoweredHLI
886.1570Ophthalmoscope, Battery-PoweredHLJ
886.1570Ophthalmoscopes, Replacement Batteries, Hand-HeldMSG
886.1780Retinoscope, AC-PoweredHKL
886.1945Transilluminator, AC-PoweredHJM
886.4150Tubing, Replacement, Phacofragmentation UnitMSR
886.4250Unit, Electrolysis, AC-Powered, OphthalmicHRO
886.4335Headlight, Fiberoptic FocusingFCT
886.4335Light, Headband, SurgicalFSR
886.4335Headlamp, Operating, AC-PoweredHPQ
886.4400Locator, Metal, ElectronicHPM
886.4440Magnet, AC-PoweredHPO
886.4790Sponge, OphthalmicHOZ
886.4790Eye TrayOJK
888.1240Dynamometer, AC-PoweredLBB
888.4580Instrument, Surgical, Sonic and Accessory/AttachmentJDX
888.4580System, Cement Removal ExtractionLZV
890.1450Hammer, Reflex, PoweredIKO
890.5100Bath, Hydro-MassageILJ
890.5100Bath, Sitz, PoweredILM
890.5110Bath, ParaffinIMC
890.5250Cabinet, Moist SteamIMB
890.5360Exerciser, MeasuringISD
890.5500Lamp, Infrared, Therapeutic HeatingILY
890.5575Device, Warning, Overload, External Limb, PoweredIRN
892.1000MRI Disposable KitOIM
892.1560Biopsy Needle Guide KitOIJ
892.1610Aperature, RadiographicIZS
892.1610Cone, RadiographicIZT
892.1610Collimator, Automatic, RadiographicIZW
892.1610Collimator, Manual, RadiographicIZX
892.1610Device, Beam Limiting, X-Ray, DiagnosticKPW
892.1650Arthrogram TrayOII
892.1650Radiology Dental TrayOIK
892.1670Device, Spot-FilmIXL
892.1680Radiographic Contrast TrayOIO
892.1680Radiology Diagnostic KitOIP
892.1730Discography KitOIL
892.1820Chair, PneumocephalographicHBK
892.1850Cassette, Radiographic FilmIXA
892.1860Changer, Radiographic Film/CassetteKPX
892.1870Programmer, Changer, Film/Cassette, RadiographicIZP
892.1900Controller, Temperature, RadiographicEGT
892.1900Dryer, Film, RadiographicEGW
892.1900Processor, Radiographic-Film, Automatic, DentalEGY
892.1900Processor, Radiographic-Film, AutomaticIXW
892.1900Processor, Cine FilmIXX
892.2030Digitizer, Image, RadiologicalLMA
892.2030Digitizer, Images, OphthalmicNFH
892.2040Camera, Multi Format, RadiologicalLMC
892.2040Device, Hardcopy, Images, OphthalmicNFI
892.5730Prostate Seeding KitOIN
Start Printed Page 31981

In table 2, FDA is identifying a list of class II devices that no longer require premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in §§ 862.9 to 892.9, as well as the indicated partial exemption limitations. Devices listed in table 2 are now exempt, but only if they are in concurrent compliance with both the partial exemption limitation specified in table 2 and its corresponding general limitation found in the .9 section of Parts 862 to 892 of Title 21 of the CFR.

Table 2—Class II Devices

21 CFR SectionDevice typeExempt product codeFormer product code (non-exempt)Partial exemption limitation
862.3100Enzyme Immunoassay, AmphetaminePUXDKZExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100Radioimmunoassay, AmphetaminePUXDJPExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100Thin Layer Chromatography, AmphetaminePUXDITExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100Gas Chromatography, AmphetaminePUXDODExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100Liquid Chromatography, AmphetaminePUXDNIExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3100Free Radical Assay, AmphetaminePUXDJLExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150Enzyme Immunoassay, BarbituratePUYDISExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
Start Printed Page 31982
862.3150Radioimmunoassay, BarbituratePUYDKNExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150Thin Layer Chromatography, BarbituratePUYDKXExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150Mercury Dithiazone, Colorimetry, BarbituratePUYDJNExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150Hemagglutination Inhibition, BarbituratePUYDLXExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150Gas Liquid Chromatography, BarbituratePUYDMFExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3150High Pressure Liquid Chromatography, BarbituratePUYKZYExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170Enzyme Immunoassay, BenzodiazepinePUZJXMExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170High Pressure Liquid Chromatography, BenzodiazepinePUZLAAExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
Start Printed Page 31983
862.3170Test, Benzodiazepine, Over The CounterPUZNFVExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170Gas Chromatography, BenzodiazepinePUZKZZExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3170Thin Layer Chromatography, BenzodiazepinePUZLABExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250Enzyme Immunoassay, Cocaine and Cocaine MetabolitesPVADIOExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250Radioimmunoassay, Cocaine MetabolitePVAKLNExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250Enzyme Immunoassay, CocainePVAJXOExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250Hemagglutination, Cocaine Metabolites (Benzoylecgonine)PVADLNExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250Thin Layer Chromatography, CocainePVADMNExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
Start Printed Page 31984
862.3250Free Radical Assay, CocainePVADIRExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250Gas Chromatography, CocainePVADINExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250Thin Layer Chromatography, BenzoylecgoninePVADOMExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3250High Pressure Liquid Chromatography, Cocaine and Cocaine MetabolitesPVALACExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3270High Pressure Liquid Chromatography, CodeinePVBLAEExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3270Thin Layer Chromatography, CodeinePVBDLDExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3270Gas Chromatography, CodeinePVBLADExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3580Radioimmunoassay, LSD (125-I)PVCDLBExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
Start Printed Page 31985
862.3580Free Radical Assay, LSDPVCDOLExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610Gas Chromatography, MethamphetaminePVDLAFExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610Thin Layer Chromatography, MethamphetaminePVDDJCExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610High Pressure Liquid Chromatography, MethamphetaminePVDLAGExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3610Test, Methamphetamine, Over The CounterPVDNGGExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620Enzyme Immunoassay, MethadonePVEDJRExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620Hemagglutination Inhibition, MethadonePVEDIWExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620Gas Chromatography, MethadonePVEDMBExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
Start Printed Page 31986
862.3620Thin Layer Chromatography, MethadonePVEDKRExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620Liquid Chromatography, MethadonePVEDNTExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3620Free Radical Assay, MethadonePVEDPPExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3630Radioimmunoassay, MethaqualonePVFKXSExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640Thin Layer Chromatography, MorphinePVGDNKExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640Radioimmunoassay, Morphine (123-I), Goat Antibody Ammonium Sulfate Sep.PVGDOEExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640Fluorometry, MorphinePVGDJJExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640Liquid Chromatography, MorphinePVGDPKExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
Start Printed Page 31987
862.3640Gas Chromatography, MorphinePVGDMYExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640Hemagglutination Inhibition, MorphinePVGDLRExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640Free Radical Assay, MorphinePVGDOKExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640Radioimmunoassay, Morphine (3-H), Goat Antibody Ammonium Sulfate Sep.PVGDIQExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3640Radioimmunoassay, Morphine-Barbiturate (125-I), Goat AntibodyPVGDNAExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650Enzyme Immunoassay, OpiatesPVHDJGExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650Gas Chromatography, OpiatesPVHDJFExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650Hemagglutination, OpiatesPVHDLTExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
Start Printed Page 31988
862.3650Thin Layer Chromatography, OpiatesPVHLAIExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650Free Radical Assay, OpiatesPVHDKTExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3650High Pressure Liquid Chromatography, OpiatesPVHLAHExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700Enzyme Immunoassay, PropoxyphenePVIJXNExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700Thin Layer Chromatography, PropoxyphenePVIDPNExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700Gas Chromatography, PropoxyphenePVILAJExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3700High Pressure Liquid Chromatography, PropoxyphenePVILAKExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3870Enzyme Immunoassay, CannabinoidsPVJLDJExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
Start Printed Page 31989
862.3870Reagents, Test, TetrahydrocannabinolPVJDKEExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3870Radioimmunoassay, Cannabinoid(S)PVJLATExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3910High Pressure Liquid Chromatography, Tricyclic Antidepressant DrugsPVKLFIExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3910U.V. Spectrometry, Tricyclic Antidepressant DrugsPVKLFHExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
862.3910Thin Layer Chromatography, Tricyclic Antidepressant DrugsPVKMLKExemption is limited to test systems intended for employment and insurance testing that include a statement in their labeling that the device is intended solely for use in employment and insurance testing, and does not include test systems intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military.)
866.5750System, Test, Radioallergosorbent (RAST) ImmunologicalPUWDHBExemption is limited to devices classified under 21 CFR 866.5750 that are intended to detect any of the allergens included in table 3 of this document.
868.2385Analyzer, Nitrogen DioxidePUGMRQExemption is limited to standalone nitrogen dioxide analyzers and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy.
870.1330Wire, Guide, CatheterPTLDQXExemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires.
870.1650Syringe, Balloon InflationPTMMAVExemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon.
870.2770Analyzer, Body CompositionPUHMNWExemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition.
870.4400Reservoir, Blood, Cardiopulmonary BypassPTNDTNExemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters.
874.1090Tester, Auditory ImpedancePTOETYExemption is limited to auditory impedance testers that are in compliance with FDA-recognized consensus standard ANSI S3.39.
874.1090TympanometerPTPNASExemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39.
876.1500Endoscopic Magnetic RetrieverPTQFCCExemption is limited to endoscopic magnetic retrievers intended for single use.
876.1500Scissors For CystoscopePTRKGDExemption is limited to sterile scissors for cystoscope intended for single use.
Start Printed Page 31990
876.1500Endoscopic Grasping/Cutting Instrument, Non-PoweredPTSOCZExemption is limited to disposable, non-powered endoscopic grasping/cutting instruments intended for single use.
876.5010Catheter, Biliary, SurgicalPTTGCAExemption is limited to surgical biliary catheters that do not include a balloon component.
876.5630Catheter, Peritoneal, Long-Term IndwellingPTUFJSExemption is limited to non-patient contacting catheter finger grips intended for single use.
876.5630Catheter, Peritoneal Dialysis, Single UsePTVFKOExemption is limited to non-patient contacting catheter finger grips intended for single use.
876.5630System, Peritoneal, Automatic DeliveryPTWFKXExemption is limited to continuous ambulatory peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales.
878.4370Drape, SurgicalPUIKKXExemption is limited to surgical drapes that do not include an antimicrobial agent.
878.4495Suture, Nonabsorbable, Steel, Monofilament And Multifilament, SterilePTXGAQExemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs.
882.1470Computerized Cognitive Assessment AidPTYPKQExemption is limited to computerized cognitive assessment aids that are not intended for diagnostic assessment of specific diseases or conditions and rely on inputs from visual cues, auditory cues, and/or functional use of the hand.
884.1630Colposcope (and Colpomicroscope)PTZHEXExemption is limited to standard colposcopes (and colpomicroscopes) that use only a white light source, do not use filters other than a green filter, do not include image analysis software, and are not smartphone-based.
884.4530Tenaculum, UterinePUAHDCExemption is limited to sterile uterine tenaculum devices that do not use suction and are intended for single use.
884.6120Accessory, Assisted ReproductionPUBMQGExemption is limited to simple embryo incubators with temperature, gas, and humidity control only; syringe pumps; collection tube warmers; dish/plate/microscope stage warmers; and controlled-rate cryopreservation freezers.
884.6130Microtools, Assisted Reproduction (Pipettes)PUCMQHExemption is limited to assisted reproduction microtools (pipettes) manufactured from glass.
884.6160Labware, Assisted ReproductionPUDMQKExemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures.
886.1850Biomicroscope, Slit-Lamp, AC-PoweredPUEHJOExemption is limited to slit-lamp, AC-powered biomicroscopes intended only for the visual examination of the anterior segment of the eye, are classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, do not provide any quantitative output, and are not intended for screening or automated diagnostic indications.
886.3320Ocular PegPUFMQUExemption is limited to ocular pegs supplied sterile.

In table 2, FDA included devices classified under § 866.5750 (Radioallergosorbent (RAST) immunological test system). FDA does not believe that all devices classified under this regulation meet the exemption criteria from premarket notification requirements. The devices listed in table 3 are also classified under § 866.5750, but this subset no longer requires premarket notification under section 510(k) of the FD&C Act, subject to the general limitations to the exemptions found in § 866.9. While the non-exempt devices classified under § 866.5750 will retain product code “DHB”, these devices listed in table 3 are reassigned product code “PUW.”

Table 3—Class II Devices

[§ 866.5750—Radioallergosorbent (RAST) Immunological Test Systems]

Allergen codeAllergen productSource (taxonomical name)
Grass Pollens
g1Sweet vernal grassAnthoxanthum odoratum.
g3Cocksfoot grass, Orchard grassDactylis glomerata.
g4Meadow fescueFestuca elatior.
g5Rye-grass (perennial rye grass)Lolium perenne.
g7Common reed (common reed grass)Phragmites communis.
g8Meadow grass, Kentucky blue (June grass)Poa pratensis.
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g9Redtop, BentgrassAgrostis stolonifera Agrostis gigantea (Agrostis alba).
g11Brome grassBromus inermis.
g12Cultivated rye (cultivated rye grass)Secale cereale.
g13Velvet grassHolcus lanatus.
g14Cultivated oat (cultivated oat grass)Avena sativa.
g15Cultivated wheat (cultivated wheat grass)Triticum aestivum (Triticum spp.).
g16Meadow foxtail (meadow foxtail grass)Alopecurus pratensis.
g17Bahia grassPaspalum notatum.
g24Wheat grass, WesternAgropyron smithii (Elymus smithii).
g30Bluegrass, annualPoa annua.
g70Wild rye grassElymus triticoides Elymus condensatus.
g71Canary grassPhalaris arundinacea.
g201Barley, cultivatedHordeum vulgare.
g202Maize, corn (cultivated corn)Zea mays.
g203Salt grassDistichlis spicata.
g204False oat-grassArrhenatherum elatius.
g216Cyn d 1Cynodon dactylon.
g701Phl p 1.0102, Phl p 5.0101Phleum pratense.
g702Phl p 7.0101Phleum pratense.
g703Phl p 12.0101Phleum pratense.
Weed Pollens
w2Western ragweedAmbrosia psilostachya.
w4False ragweedAmbrosia acanthicarpa (Franseria acanthicarpa).
w5WormwoodArtemisia absinthium Artemisia annua.
w6MugwortArtemisia vulgaris.
w7Marguerite, ox-eye daisyChrysanthemum leucanthemum.
w8DandelionTaraxacum vulgare Taraxacum officinale.
w9Plantain (English), RibwortPlantago lanceolata.
w10Goosefoot, lamb's quartersChenopodium album.
w11Saltwort (prickly), Russian thistleSalsola kali (Salsola pestifer).
w12GoldenrodSolidago virgaurea (Solidago spp.)
w13Cocklebur, commonXanthium commune.
w14Common pigweed (rough pigweed)Amaranthus retroflexus.
w15Scale, LenscaleAtriplex lentiformis.
w16Rough marsh elderIva ciliate Iva annua.
w17Firebush (Kochia)Kochia scoparia.
w18Sheep sorrelRumex acetosella.
w19Wall pellitoryParietaria officinalis.
w20Nettle (Common stinging nettle)Urtica dioica.
w21Wall pellitoryParietaria judaica.
w22Japanese hop (careless weed)Humulus japonicas (Humulus scandens).
w23Yellow dock, Yellow dockweedRumex crispus.
w24Spiny pigweedAmaranthus spinosus.
w27CarnationDianthus spp.
w28RoseRosa rugosa.
w33CloverTrifolium pratense.
w35Mexican teaChenopodium ambrosioides.
w36Rabbit bushAmbrosia deltoidea (Franseria deltoides).
w37Salt bush, annualAtriplex wrightii.
w39Water hemp, WesternAmaranthus rudis (Acnida tamariscina).
w41BurrobrushHymenoclea salsola.
w42Poverty weed
w43Common sagebrushArtemisia tridentata.
w45AlfalfaMedicago sativa.
w46Dog fennelEupatorium capillifolium.
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w53GeraniumGeranium spp.
w67Groundsel bushBaccharis halimifolia.
w69Iodine bushAllenrolfea occidentalis.
w70Ragweed, slenderAmbrosia confertiflora.
w75Wing scale (wingscale)Atriplex canescens.
w82Careless weedAmaranthus palmeri Amaranthus hybridus.
w90Japanese hopHumulus japonicas (Humulus scandens).
w203Rape (rape pollen)Brassica napus.
w204SunflowerHelianthus annuus.
w206CamomileMatricaria chamomilla.
w207LupinLupinus spp.
w210Sugar-beetBeta vulgaris.
w211Par j 2.0101Parietaria judaica.
w231Art v 1Artemisia vulgaris (Mugwort).
w232Sal k 1Salsola kali.
w233Art v 3Artemisa vulgaris (LTP, Mugwort).
w234Pla l 1Plantago lanceolata.
w235Che a 1.0101Chenopodium album.
w236Mer a 1.0101Mercurialis annua.
a753Art v 1Artemisia vulgaris (Mugwort weed).
Tree Pollens
t1Box-elder (Maple)Acer negundo. Acer saccharum.
t2Gray alder, speckled alder (alder)Alnus incana.
t4Hazel, hazelnutCorylus avellana. Corylus americana.
t5American beech (beech)Fagus grandifolia. (Fagus americana).
t6Mountain juniper, Mountain cedarJuniperus ashei (Juniperus sabinoides).
t8ElmUlmus americana.
t9OliveOlea europaea.
t10WalnutJuglans californica Juglans nigra.
t11Maple leaf sycamore, London plane, Plane treePlatanus acerifolia.
t61SycamorePlatanus occidentalis.
t12WillowSalix caprea Salix nigra.
t14Cottonwood (Eastern Cottonwood/Black Cottonwood)Populus deltoides.
t15White ashFraxinus americana.
t16White pinePinus strobus.
t18Eucalyptus, gum-treeEucalyptus globulus. (Eucalyptus spp.).
t19/t26AcaciaAcacia longifolia (Acacia spp.).
t20MesquiteProsopis glandulosa/ Prosopis juliflora.
t21Melaleuca, cajeput treeMelaleuca quinquenervia (Melaleuca leucadendron).
t22Pecan, hickoryCarya illinoinensis (Carya pecan).
t23Italian/Mediterranean/funeral cypressCupressus sempervirens.
t24Japanese cypressChamaecyparis obtusa (Chamaecyparis spp.).
t25AshFraxinus excelsior.
t27Maple, redAcer rubrum.
t29AcaciaAcacia spp.
t30Birch, whiteBetula populifolia.
t32Willow, blackSalix nigra.
t33Ash, ArizonaFraxinus velutina.
t35Cedar, saltTamarix gallica.
t37Bald cypress (white bald cypress)Taxodium distichum.
t38Elm, Chinese/SiberianUlmus pumila.
t40Hazelnut treeCorylus americana.
t41White hickoryCarya alba (Carya tomentosa).
t42Oak, redQuercus rubra.
t43Loblolly pinePinus taeda.
t44HackberryCeltis occidentalis.
Start Printed Page 31993
t45Cedar elmUlmus crassifolia.
t47Juniper, one seedJuniperus monosperma.
t48Pine, lodgepolePinus contorta.
t49Pine, ponderosaPinus ponderosa.
t50Beech, EuropeanFagus sylvatica.
t51Tree of HeavenAilanthus altissima.
t52Western white pinePinus monticola.
t54Russian oliveElaeagnus angustifolia.
t55Scotch broomCytisus scoparius.
t56BayberryMyrica cerifera.
t57Red cedarJuniperus virginiana.
t60Western juniperJuniperus occidentalis.
t61SycamorePlatanus occidentalis.
t70Mulberry (white mulberry)Morus alba.
t71Red mulberryMorus rubra.
t72Queen palmArecastrum romanzoffiamon.
t73Australian pineCasuarina equisetifolia.
t77Oak mix (red, white, black)Quercus spp.
t80Japanese cypressChamaecyparis obtusa.
t81Japanese alderAlnus japonica.
t83Mango treeMangifera indica.
t90Walnut, blackJuglans nigra.
t96Poplar, white (poplar)Populus alba.
t103/ t218Virginia live oak (live oak)Quercus virginiana.
t105Pepper treeSchinus molle.
t110Orange treeCitrus sinensis.
t201Spruce, Norway sprucePicea abies (Picea excelsa).
t202Alder, smoothAlnus incana spp. Rugosa (Alnus rugosa).
t203Horse chestnutAesculus hippocastanum.
t205ElderSambucus nigra.
t206ChestnutCastanea sativa.
t207Douglas firPseudotsuga menziesii (Pseudotsuga taxifolia).
t208LindenTilia cordata.
t209Horn beamCarpinus betulus.
t210PrivetLigustrum vulgare.
t211Sweet gumLiquidambar styraciflua.
t212CedarLibocedrus decurrens.
t213PinePinus radiata.
t214Date palmPhoenix canariensis.
t215LilacSyringa vulgaris.
t217Pepper treeSchinus molle.
t217Red alderAlnus rubra.
t218Virginia live oakQuercus virginiana.
t218Bayberry (bayberry/sweet gale)Myrica gale.
t219Palo verdeCercidium floridum.
t219Red cedarJuniperus virginiana.
t220Bet v 4Betula verrucosa (Birch).
t221Bet v 2.0101, Bet v 4Betula verrucosa (Birch).
t222Cypress (Arizona cypress)Cupressus arizonica.
t223Oil palmElaeis guineensis.
t224Ole e 1Olea europaea.
t225Bet v 6Betula verrucosa (Birch).
t226Cup a 1Cupressus arizonica.
t227Ole e 7Olea Europaea.
t228Aspen, quakingPopulus tremuloides.
t229Eastern hemlockTsuga canadensis.
t230Redwood (sequoia)Sequoia sempervirens.
t232Pussy willowSalix discolor.
t240Ole e 9.0101Olea Europaea.
t241Pla a 1.0101Platanus acerifolia.
t242Pla a 2Platanus acerifolia.
t243Pla a 3.0101Platanus acerifolia.
t244Cor a 1.0103Corylus avellana.
t245Aln g 1.0101Alnus glutinosa.
t246Cry j 1Cryptomeria japonica.
t280Locust treeRobinia pseudoacacia.
t401Brazilian peppertreeSchinus terebinthifolius.
t402Mastic treePistacia lentiscus.
Start Printed Page 31994
t404Tree of heavenAilanthus altissima.
t406Date palmPhoenix dactylifera.
a482Ole e 1Olea europaea (Olive Oil).
Mites
d207Blo t 5.0101Blomia tropicalis.
d208Lep d 2.0101Lepidoglyphus destructor.
Microorganisms, Molds, Yeast
m1Penicillium chrysogenum (Penicillium notatum)Penicillium chrysogenum (Penicillium notatum).
m2Cladosporium herbarum (Hormodendrum)Cladosporium herbarum (Hormodendrum).
m3Aspergillus fumigatusAspergillus fumigatus.
m4Mucor racemosusMucor racemosus.
m5Candida albicansCandida albicans.
m7Botrytis cinereaBotrytis cinerea.
m8Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum)Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes).
m9Fusarium moniliforme (Fusarium proliferatum)Fusarium moniliforme (Fusarium proliferatum).
m10Stemphylium botryosumStemphylium herbarum (Stemphylium botryosum).
m11Rhizopus nigricansRhizopus nigricans.
m12Aureobasidium pullulansAureobasidium pullulans.
m13Phoma betaePhoma betae.
m14Epicoccum purpurascensEpicoccum purpurascens (Epicoccum nigrum).
m15Trichoderma virideTrichoderma viride.
m16Curvularia lunataCurvularia lunata Curvularia specifera (K923044).
m17Cladosporium fulvumCladosporium fulvum.
m18Fusarium culmorumFusarium culmorum.
m19Aspergillus versicolorAspergillus versicolor.
m20Mucor mucedoMucor mucedo.
m21Aspergillus clavatusAspergillus clavatus.
m22Micropolyspora faeniSaccharopolyspora rectivirgula (Micropolyspora faeni).
m23Thermoactinomyces vulgarisThermoactinomyces vulgaris.
m24Stachybotrys atraStachybotrys chartarum (Stachybotrys atra).
m24Paecilomyces spp.Paecilomyces spp.
m25Aspergillus versicolorAspergillus versicolor.
m25Penicillium brevicompactumPenicillium brevicompactum.
m26Cladosporium cladosporioidesCladosporium cladosporioides.
m26Penicillium citrinumPenicillium citrinum.
m27Penicillium spp.Penicillium spp.
m29Aspergillus repensAspergillus repens.
m30Penicillium roquefortiPenicillium roqueforti.
m32Cladosporium cladosporioidesCladosporium cladosporioides.
m34Serpula lacrymansSerpula lacrymans.
m36Aspergillus terreusAspergillus terreus.
m37Trichophyton mentagrophytesTrichophyton mentagrophytes.
m40Aspergillus amstelodamiAspergillus amstelodami.
m43Saccharomyces carlsbergSaccharomyces carlsbergensis.
m44Saccharomyces cerevisiaeSaccharomyces cerevisiae.
m45Hormodendrum hordeiHormodendrum hordei.
m46Bipolaris spiciferaBipolaris spicifera.
m47Aspergillus nidulansAspergillus nidulans.
m48Aspergillus oryzaeAspergillus oryzae.
m49Fusarium oxysporumFusarium oxysporum.
m50Micropolyspora faeniSaccharopolyspora rectivirgula (Micropolyspora faeni).
m51Thermoactinomyces vulgarisThermoactinomyces vulgaris.
m53Microspora canisMicrosporum canis (Microspora canis).
m54Aspergillus flavusAspergillus flavus.
m63Helminthosporium interseminHelminthosporium intersemin.
m66Mucor plumbeusMucor plumbeus.
m67MycogoneMycogone perniciosa.
m68Nigrospora oryzaeNigrospora oryzae.
Start Printed Page 31995
m69RhodotorulaRhodotorula rubra (Rhodotorula mucilaginosa).
m70Malassezia furfur (Pityrosporum orbiculare)Malassezia furfur (Pityrosporum orbiculare).
m71SpondylocladiumSpondylocladium spp.
m72EpidermophytonEpidermophyton floccosum.
m73Epicoccum nigrumEpicoccum purpurascens (Epicoccum nigrum).
m80Staphylococcal enterotoxin A (Sta a SEA)Staphylococcus aureus.
m80Helminthosporium spp.Helminthosporium spp.
m81Staphylococcal enterotoxin B (Sta a SEB)Staphylococcus aureus.
m88Stemphylium solaniStemphylium solani.
m93Gliocladium fimbriatumGliocladium fimbriatum.
m94Phycomyces blakesleeanusPhycomyces blakesleeanus.
m201Tilletia tritici (Ustilago nuda, Ustilago tritici) (Barley smut)Tilletia tritici (Ustilago nuda, Ustilago tritici).
m202Acremonium kiliense (Cephalosporium acremonium)Acremonium kiliense (Cephalosporium acremonium).
m203Trichosporon pullulansTrichosporon pullulans.
m204Ulocladium chartarumUlocladium chartarum.
m205Trichophyton rubrumTrichophyton rubrum.
m207Aspergillus nigerAspergillus niger.
m208Chaetomium globosumChaetomium globosum.
m209Penicillium frequentansPenicillium glabrum (Penicillium frequentans).
m209Stachybotrys chartarumStachybotrys chartarum (Stachybotrys atra).
m210Trichophyton mentagrophytes var. goetziiTrichophyton mentagrophytes var. goetzii.
m211Trichophyton mentagrophytes var. interdigitaleTrichophyton mentagrophytes var. interdigitale.
m211Oat smutUstilago avenae.
m212Micropolyspora faeniSaccharopolyspora rectivirgula (Micropolyspora faeni).
m212Geotrichum candidumGeotrichum candidum.
m213Bermuda grass smutUstilago cynodontis.
m214Johnson grass smutSphacelotheca cruenta.
m215Corn smutUstilago maydis.
m218Asp f 1.0101Aspergillus fumigatus.
a3050Asp r 1Aspergillus restrictus.
m219Asp f 2Aspergillus fumigatus.
m220Asp f 3.0101Aspergillus fumigatus.
m221Asp f 4Aspergillus fumigatus.
m222Asp f 6.0101Aspergillus fumigatus.
m223Staphylococal enterotoxin C (Sta a SEC)Staphylococus aureus.
m224Staphylococcal enterotoxin D (Sta a SED)Staphylococcus aureus.
m226Staphylococcal enterotoxin TSST (Sta a TSST)Staphylococcus aureus.
m227Malassezia spp. (Pityrosporum spp.)Malassezia spp. (Pityrosporum spp.).
m228Aspergillus flavus.
m229Alt a 1.0101Alternaria alternata (Alternaria tenuis).
m230Alt a 6.0101Alternaria alternata (Alternaria tenuis).
m231Cla h 8.0101Cladosporium herbarum (Hormodendrum).
m300Eurotium spp.Eurotium spp.
m304Aspergillus oryzaeAspergillus oryzae.
m305Penicillium brevicompactumPenicillium brevicompactum.
m309Aspergillus terreusAspergillus terreus.
m310Aspergillus nidulansAspergillus nidulans.
m311Aspergillus flavusAspergillus flavus.
m312Aspergillus clavatusAspergillus clavatus.
Epidermal & Animal
e6Guinea pig epitheliumCavia porcellus.
e7Pigeon droppingsColumba palumbus Columba livia.
e25Chicken serumGallus domesticus (Gallus gallus domesticus; Gallus spp.).
e26Parrot serumPsittacoidea spp.
e62CamelCamelus dromedaries.
e70Goose feathersAnser anser.
e71Mouse epitheliumMus musculus (Mus spp.).
e73Rat epitheliumRattus norvegicus.
e74Rat urine proteinsRattus norvegicus Rattus rattus.
Start Printed Page 31996
e75Rat serum proteinsRattus norvegicus Rattus rattus.
e76Mouse serum proteinsMus musculus (Mus spp.).
e77Budgerigar droppingsMelopsittacus undulatus.
e78Budgerigar feathersMelopsittacus undulatus.
e79Budgerigar serum proteinsMelopsittacus undulatus.
e80Goat epitheliumCapra hircus.
e81Sheep epitheliumOvis aries (Ovis spp.).
e82Rabbit epitheliumOryctolagus cuniculus (Oryctolagus spp.).
e83Swine epitheliumSus scrofa (Sus scrofa domesticus; Sus spp.).
e84Hamster epitheliumCricetus cricetus, Mesocricetus auratus, and Phodopus sungorus.
e85Chicken feathersGallus domesticus (Gallus gallus domesticus; Gallus spp.).
e86Duck feathersAnas platyrhynchos.
e87Rat epithelium, serum proteins, and urine proteinsRattus norvegicus Rattus rattus.
e88Mouse epithelium, serum proteins, and urine proteins (mouse)Mus musculus (Mus spp.).
e89Turkey feathersMeleagris gallopavo.
e90Budgerigar serum proteins, feathers, and droppingsMelopsittacus undulatus.
e91Pigeon serum proteins, feathers, and droppingsStreptopelia roseogrisea Psittacidae spp.
e92Parrot serum proteins, feathers, and droppingsAra spp.
e93Pigeon serum proteinsStreptopelia roseogrisea.
e94Fel d 1.0101Felis domesticus.
a345Fel d 1Felis domesticus.
e98Parrot droppingsPsittacoidea spp.
e101Can f 1.0101Canis familiaris (Canis domesticus).
a174Can f 1Canis familiaris (Canis domesticus).
e102Can f 2.0101Canis familiaris (Canis domesticus).
e196Parakeet feathersNymphicus hollandicus.
e197Parakeet droppingsNymphicus hollandicus.
e198Parakeet serumNymphicus hollandicus.
e199Canary bird serumSerinus canarius.
e200Canary bird droppingsSerinus canarius.
e201Canary bird feathers (Canary feathers)Serinus canarius.
e202Reindeer epitheliumRangifer tarandus.
e203Mink epitheliumMustela spp.
e204Bos d 6Bos domesticus (Bos taurus; Bos spp.).
e205Horse, serum proteinsEquus caballus (Equus spp.).
e206Rabbit, serum proteinsOryctolagus cuniculus (Oryctolagus spp.).
e208Chinchilla epitheliumChinchilla laniger.
e209Gerbil epitheliumMeriones unguiculatus.
e210Fox epitheliumVulpes vulpes.
e211Rabbit, urine proteinsOryctolagus cuniculus (Oryctolagus spp.).
e212Swine, urine proteinsSus scrofa (Sus scrofa domesticus; Sus spp.).
e213Parrot feathersAra spp.
e214Finch feathersLonchura domestica.
e215Pigeon feathersStreptopelia roseogrisea (Streptopelia spp.) Columbia spp.
e216Deer epitheliumDama dama.
e217Ferret epitheliumMustela putorius.
e218Chicken droppingsGallus domesticus (Gallus gallus domesticus; Gallus spp.).
e219Chicken, serum proteinsGallus domesticus (Gallus gallus domesticus; Gallus spp.).
e220Fel d 2, Cat serum albuminFelis domesticus.
e221Can f 3Canis familiaris (Canis domesticus) (Dog serum albumin).
e222Swine serum albumin (Sus s PSA)Sus scrofa (Sus scrofa domesticus; Sus spp.).
e225Lovebird feathersPsittacoidea agapomis.
e226Can f 5.0101Canis familiaris.
e227Equ c 1.0101Equus caballus.
e228Fel d 4.0101Felis domesticus.
e230Equ c 3Equus caballus.
Start Printed Page 31997
e231Mus m 1Mus musculus.
Food
f9RiceOryza sativa.
f12Pea (green pea)Pisum sativum.
f15White beanPhaseolus vulgaris.
f19Cayenne pepperCapsicum frutescens (Capsicum annum).
f21Sugar caneSaccharum officinarum.
f22RaspberryRubus idaeus.
f26PorkSus scrofa (Sus scrofa domesticus; Sus spp.).
f29WatermelonCitrullus lanatus (Citrullus vulgaris).
f31CarrotDaucus carota.
f32Oyster mushroomPleurotus ostreatus.
f33OrangeCitrus sinensis.
f35PotatoSolanum tuberosum.
f43Mother's milkHomo sapiens.
f44StrawberryFragaria vesca (Fragaria spp.).
f45Yeast, baker'sSaccharomyces cerevisiae.
f46Pepper, RedCapsicum annuum.
f47GarlicAllium sativum.
f48OnionAllium cepa.
f49AppleMalus x domestica (Malus spp.).
f51Bamboo shootPhyllostachys pubescens.
f52Cacao/chocolateTheobroma cacao.
f54Sweet potatoIpomoea batatas.
f55Common milletPanicum miliaceum.
f56Foxtail milletSetaria italica.
f57Japanese milletEchinochloa crus-galli.
f58Pacific squidTodarodes pacificus.
f59OctopusOctopus vulgaris (Octopus spp.).
f63KefirNA.
f67Parmesan cheeseNA.
f81Cheese, cheddar typeNA.
f82Cheese, mold typeNA.
f83ChickenGallus domesticus (Gallus gallus domesticus; Gallus spp.).
f86ParsleyPetroselinum crispum.
f87MelonCucumis melo Cucumis melo + Citrullus lanatus.
f88Mutton (lamb)Ovis aries (Ovis spp.).
f90MaltHordeum vulgare.
f92BananaMusa spp.
f93CacaoTheobroma cacao.
f94PearPyrus communis (Pyrus spp.).
f97YamDioscorea spp. Dioscorea opposita.
f97Chamomile teaMatricaria chamomilla.
f98GliadinTriticum aestivum (Triticum spp.).
f102CantaloupeCucumis melo var. cantalupensis.
f105ChocolateTheobroma cacao.
f109CottonseedGossypium hirsutum.
f110Giant radishRaphanus sativus.
f118ZucchiniCucurbita pepo.
f119RadishRaphanus sativus.
f120VenisonCapreolus capeolus.
f121Pinto beanPhaseolus vulgaris.
f122Cheese, AmericanNA.
f127Black-eyed peaVigna unguiculata.
f131Black OliveOlea europaea.
f136Red beetBeta vulgaris var. conditiva.
f139Goat's CheeseCapra aegagrus.
f140BranNA.
f141Corn (vegetables)Zea mays.
f152Green bell pepperCapsicum annuum.
f155Brewer's yeastSaccharomyces carlsbergensis.
f157DuckAnas domesticus.
f158GooseAnser anser.
f160Camembert cheeseNA.
Start Printed Page 31998
f162NectarinePrunus persica var. nucipersica.
f163KohlrabiBrassica oleracea var. gongylodes.
f65Perch
f166LeekAllium porrum.
f170Cheese (Switzerland) (Swiss cheese)NA.
f174FigFicus carica.
f177CranberryVaccinium macrocarpon.
f179RaisinVitis spp.
f182Lima beanPhaseolus lunatus.
f198Flaxseed (bruised grain)Linum usitatissimum.
f199Untreated native milkBos domesticus (Bos taurus; Bos spp.).
f208LemonCitrus limon.
f209GrapefruitCitrus paradisi.
f210PineappleAnanas comosus.
f211BlackberryRubus fruticosus.
f212Mushroom (champignon)Agaricus hortensis (Agaricus spp.).
f213RabbitOryctolagus cuniculus (Oryctolagus spp.).
f214SpinachSpinacia oleracea.
f215LettuceLactuca sativa.
f216CabbageBrassica oleracea var. capitata.
f217Brussels sproutsBrassica oleracea var. gem.
f218Paprika, sweet pepperCapsicum annuum.
f219Fennel seedFoeniculum vulgare.
f219SageSalvia officinalis.
f220CinnamonCinnamomum spp.
f221CoffeeCoffea spp.
f222TeaCamellia sinensis.
f223Green oliveOlea europaea.
f225Summer squash, pumpkinCucurbita pepo.
f225PumpkinCucurbita maxima.
f226Pumpkin seedCucurbita pepo.
f227Sugar-beet seedBeta vulgaris.
f229Safflower SeedCarthamus tinctorius.
f231Milk, boiledBos domesticus (Bos taurus; Bos spp.).
f234VanillaVanilla planifolia.
f237ApricotPrunus armeniaca.
f241Gouda cheeseNA.
f242CherryPrunus avium.
f244CucumberCucumis sativus.
f246Guar, guar gumCyamopsis tetragonoloba.
f247HoneyNA.
f248RosemaryRosmarinus officinalis.
f254PlaicePleuronectes platessa.
f255PlumPrunus domestica Prunus americana.
f258SquidLoligo spp.
f259GrapeVitis vinifera (Vitis spp.).
f260BroccoliBrassica oleracea var. italica (Brassica oleracea var. cultivar).
f261AsparagusAsparagus officinalis.
f262Aubergine, eggplantSolanum melongena.
f263Green pepperPiper nigrum Capsicum annuum.
f264EelAnguilla anguilla.
f265CarawayCarum carvi.
f265CuminCuminum cyminum.
f266MaceMyristica fragrans.
f267CardamonElettaria cardamomum.
f268CloveSyzygium aromaticum.
f269BasilOcimum basilicum.
f270GingerZingiber officinale.
f271AnisePimpinella anisum.
f272TarragonArtemisia dracunculus.
f273ThymeThymus vulgaris.
f274MarjoramOriganum majorana.
f275LovageLevisticum officinale.
f276Fennel, freshFoeniculum vulgare.
Start Printed Page 31999
f277DillAnethum graveolens.
f278Bay leafLaurus nobilis.
f279Chili pepperCapsicum frutescens.
f280Black pepperPiper nigrum.
f281Curry (Santa Maria)NA.
f282NutmegMyristica fragrans.
f283OreganoOriganum vulgare.
f284Turkey meatMeleagris gallopavo.
f285Elk/moose meatAlces spp.
f286Mare's milkEquus caballus (Equus spp.).
f287Red kidney beanPhaseolus vulgaris.
f288BlueberryVaccinium myrtillus (Vaccinium spp.).
f289DatePhoenix dactylifera.
f291CauliflowerBrassica oleracea var. botrytis.
f292GuavaPsidium guajava.
f293PapayaCarica papaya.
f294Passion fruit, MaracujaPassiflora edulis (Passiflora spp.).
f295CarambolaAverrhoa carambola.
f296CarobCeratonia siliqua.
f297Gum arabicAcacia senegal (Acacia spp.).
f298TragacanthAstragalus spp.
f299Sweet chestnut (chestnut)Castanea sativa.
f300Pinto beanPhaseolus spp.
f301Persimmon (kaki fruit, sharon)Diospyros kaki.
f302Mandarin (tangerine, clementine, satsumas)Citrus reticulata.
f305FenugreekTrigonella foenum-graecum.
f306LimeCitrus aurantifolia.
f307HakeMerluccius merluccius.
f308Sardine (pilchard)Sardina pilchardus.
f310Blue vetchLathyrus sativus.
f311MegrimLepidorhombus whiffiagonis.
f315Green beanPhaseolus vulgaris.
f316Rape seedBrassica napus.
f317CorianderCoriandrum sativum.
f318Jack fruitArtocarpus heterophyllus.
f319BeetrootBeta vulgaris.
f320CrayfishAstacus astacus.
f321Horse meatEquus caballus (Equus spp.).
f322Red currantRibes sylvestre.
f324Hop (fruit cone)Humulus lupulus.
f325SaffronColchicum autumnale.
f328FigFicus carica.
f329WatermelonCitrullus lanatus.
f330Rose hipRosa spp.
f331SaffronCrocus sativus.
f332MintMentha piperita.
f333LinseedLinum usitatissimum.
f336JujubeZiziphus jujuba.
f336Wine vinegarVitis vinifera (Vitis spp.).
f337SoleSolea solea.
f337English soleParophrys vetulus.
f338Wine, whiteVitis vinifera (Vitis spp.).
f339AllspicePimenta dioica.
f339Wine, redVitis vinifera (Vitis spp.).
f341CranberryVaccinium oxycoccus Vaccinium macrocarpon.
f342Olive (black, fresh)Olea europaea.
f343RaspberryRubus idaeus.
f344SageSalvia officinalis.
f346ChivesAllium schoenoprasum.
f347QuinoaChenopodium quinoa.
f348LitchiLitchi chinensis.
f349Chum salmon roeOncorhynchus keta.
f358ArtichokeCynara scolymus.
f360YogurtNA.
f368Black bassMicropterus dolomieu (Micropterus dolomieui).
f374Karaya gumSterculia urens.
f375HorseradishArmoracia rusticana.
f377Maple syrupNA.
f379OkraAbelmoschus esculentus.
Start Printed Page 32000
f382Beet, sugarBeta vulgaris var. altissima.
f401LoquatEriobotrya japonica.
f402FigFicus carica.
f403Brewer's yeastSaccharomyces cerevisiae.
f405MintMentha spp.
f406ArugulaEruca vesicaria.
House Dust
h1Greer Labs., Inc.NA.
h2Hollister-Stier Labs.NA.
h6JapanNA.
Venoms & Insects
i7MidgeChironomus yoshimatsui.
i8MothBombyx mori Heterocera spp.
i47Water fleaDaphnia spp.
i49Deer flyChrysops spp.
i51Black antCamponotus pennsylvanicus.
i54Flea mix (dog/cat), common fleaCtenocephalides spp.
i71MosquitoAedes communis Aedes spp. and Culex spp.
i72Green nimittiCladotanytarsus lewisi.
i73Blood wormChironomus thummi Chironomusri parius Chironomus spp.
i75European hornetVespa crabro.
i76Berlin beetleTrogoderma angustum.
i77European paper waspPolistes dominulus.
i78FlyMusca domestica.
i80BumblebeeBombus pennsylvanicus.
i201Horse bot flyGasterophilus intestinalis.
i202Grain weevilSitophilus granarius.
i203Mediterranean flour mothEphestia kuehniella (Anagasta kuehniella).
i204Horse flyTabanus spp.
i205BumblebeeBombus terrestris.
i208Api m 1.0101Apis mellifera.
a45Api m 1Apis mellifera.
i209Ves v 5.0101Vespula vulgaris.
a670Ves v 5Vespula vulgaris.
i210Pol d 5.0101Polistes dominulus.
i211Ves v 1.0101Vespula vulgaris.
i213Api m 4Apis mellifera.
i214Api m 2Apis mellifera.
i215Api m 3Apis mellifera.
i216Api m 5Apis mellifera.
i217Api m 10Apis mellifera.
i220Bla g 1.0101Blattella germanica.
i221Bla g 2.0101Blattella germanica.
i222Bla g 5.0101Blattella germanica.
i223Bla g 7Blattella germanica
a46Api m 2Apis mellifera.
Miscellaneous
o1Cotton, crude fibersGossypium spp.
o3Cotton (treated)Gossypium spp.
o70Seminal fluidHomo sapiens.
o71Staphylococcus aureusStaphylococcus aureus.
o72Pichia pastoris crude extract customer specificPichia pastoris.
o72Sperm-sedimentHomo sapiens.
o73Pichia pastoris crude extr. vector customer specificPichia pastoris.
o74Pichia pastoris with vector customer specificPichia pastoris.
o201Tobacco leaf, tobacco dustNicotiana tabacum.
o202Artemia salina, fish feedArtemia salina.
o203Tetramin, fish feedNA.
o207Daphnia, fish feedDaphnia spp.
o211MealwormTenebrio molitor.
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o212StreptavidinStreptomyces avidini.
o213MBP (maltose binding protein)Escherichia coli.
o214CCD; MUXF3 from bromelainAnanas comosus.
o72Enterotoxin A (Sta a SEA)Staphylococcus aureus.
o73Enterotoxin B (Sta a SEB)Staphylococcus aureus.
Parasites
p1AscarisAscaris suum.
p2EchinococcusEchinococcus granulosus.
p3SchistosomaSchistosoma mansoni.
p4Anisakis (Herring Worm)Anisakis simplex (Anisakis spp.).
p5Toxocara canisToxocara canis.
p10Ani s 3.0101Anisakis simplex (Anisakis spp.).
p11Ani s 1Anisakis simplex (Anisakis spp.).
Occupational
k4Threshing dustNA.
k5FlaxNA.
k7Hay DustNA.
k8Hop (hops)Humulus lupulus.
k12Grain mill dustNA.
k14KapokNA.
k20Sheep's wool (treated) (wool)Ovis aries (Ovis spp.).
k21Sheep's wool (Untreated)Ovis aries (Ovis spp.).
k23Straw DustNA.
k33OakNA.
k70Green coffee beanCoffea spp.
k71Castor beanRicinus communis.
k72IspaghulaPlantago psyllium/Plantago ovata.
k73Silk wasteNA.
k74SilkBombyx mori.
k75Isocyanate TDI (Toluene diisocyanate)NA.
k76Isocyanate MDI (Diphenylmethane diisocyanate)NA.
k77Isocyanate HDI (Hexamethylen diisocyanate)NA.
k78Ethylene oxideNA.
k79Phthalic anhydrideNA.
k80Formaldehyde/FormalinNA.
k81FicusFicus benjamina (Ficus spp.).
k83Cotton seedGossypium hirsutum.
k84Sunflower seedHelianthus annuus.
k85Chloramin TNA.
k86Trimellitic anhydride, TMANA.
k87Asp o 21, alpha-amylaseAspergillus oryzae.
k89Orris rootIris florentina.
k99HSA (Human Serum Albumin) (Hom s HSA)Homo sapiens.
k201Car p 1, PapainCarica papaya.
k202Ana c 2, BromelainAnanas comosus.
k204MaxataseBacillus licheniformis.
k205AlcalaseBacillus spp.
k206Savinase, Protease 1 (Bac l Subtilisin)Bacillus spp.
k208Gal d 4, LysozymeGallus domesticus (Gallus gallus domesticus; Gallus spp.).
k209Hexahydrophtalic anhydridNA.
k210Maleic anhydrideNA.
k211Methyltetrahydrophtalic anhydridNA.
k212Abachi wood dustTriplochiton scleroxylon.
k213Pepsin (Sus s Pepsin)Sus scrofa (Sus scrofa domesticus; Sus spp.).
k213TCPANA.
k214BougainvilleaBougainvillea spp.
k225Horse radish peroxidase (Arm r HRP)Armoracia rusticana.
k226Ascorbate oxidase (Cuc p ascorbate oxidase)Cucurbita pepo.
k301Flour dustTriticum spp.
k501Savinase customer specificProprietary knowledge of customer.
k502Lipolase customer specificProprietary knowledge of customer.
k503Termamyl customer specificProprietary knowledge of customer.
k504Clazinase customer specificProprietary knowledge of customer.
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V. Reference

The following reference is on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

1. FDA Guidance, “Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff,” February 19, 1998, available at http://www.fda.gov/​downloads/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​UCM080199.pdf.

Start Signature

Dated: July 5, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.

End Signature End Supplemental Information

[FR Doc. 2017-14453 Filed 7-10-17; 8:45 am]

BILLING CODE 4164-01-P