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Notice

Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments.

SUMMARY:

The Food and Drug Administration (FDA or Agency) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice of that determination and requesting public comment in accordance with procedures established by the 21st Start Printed Page 13610Century Cures Act. This notice does not represent FDA's final determination with respect to the class II devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register.

DATES:

Submit either electronic or written comments on the notice by May 15, 2017. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 15, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 15, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2017-N-1129 for “Medical Devices; Exemptions from Premarket Notification: Class II Devices.” Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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, 301-348-1446, email: Gregory.Bennett@fda.hhs.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), and the amendments of the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls), if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval), if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury.

Most generic types of devices that were on the market before the date of the 1976 amendments (May 28, 1976) (generally referred to as preamendments devices) have been classified by FDA under the procedures set forth in section 513(c) and (d) of the FD&C Act through the issuance of classification regulations into one of these three regulatory classes. Devices introduced into interstate commerce for the first time on or after May 28, 1976 (generally referred to as postamendments devices) are classified through the premarket notification process under section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of the FD&C Act and the implementing regulations, part 807 of Title 21 of the Code of Federal Regulations (CFR), require persons who intend to market a new device to submit a premarket notification (510(k)) Start Printed Page 13611containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval.

On December 13, 2016, the President signed into law the 21st Century Cures Act (Pub. L. 114-255). Section 3054 of the 21st Century Cures Act amended section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act requires FDA to 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 to provide reasonable assurance of safety and effectiveness. FDA is required to publish this notice within 90 days of the date of enactment of the 21st Century Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Additionally, FDA must provide at least a 60-day comment period for any such notice required to be published under section 510(m)(1)(A) of the FD&C Act. 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 exemption of the devices that were contained in the present list published under section 510(m)(1)(A) of the FD&C Act. Section 510(m)(3) of the FD&C Act provides that upon the date of publication of the final list in the Federal Register, a 510(k) will no longer be required for these devices and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.

In a final action, and after considering comments, FDA intends to amend the codified language for each listed regulation to reflect the final determination with respect to exempt devices. FDA's final action 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 510(k) 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 guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (Ref. 1).

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 initial 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 §§ 862.9 to 892.9) 21 CFR 862.9 to 892.9, FDA may partially limit the exemption from premarket notification requirements to specific devices within a listed device type. In table 1, for example, FDA is listing the exemption of the endoscopic magnetic retriever, but limits the exemption to such devices that are for single use. All other endoscopic magnetic retrievers are still subject to premarket notification requirements because FDA determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices.

IV. List of Class II Devices

FDA is identifying the following list of class II devices that, if finalized, would 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 codePartial exemption limitation (if applicable)
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
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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
862.3100Enzyme Immunoassay, AmphetamineDKZExemption is limited to test systems intended for 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, AmphetamineDJPExemption is limited to test systems intended for 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, AmphetamineDITExemption is limited to test systems intended for 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, AmphetamineDODExemption is limited to test systems intended for 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, AmphetamineDNIExemption is limited to test systems intended for 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, BarbiturateDJLExemption is limited to test systems intended for 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, BarbiturateDISExemption is limited to test systems intended for 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.).
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862.3150Radioimmunoassay, BarbiturateDKNExemption is limited to test systems intended for 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, BarbiturateDKXExemption is limited to test systems intended for 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, BarbiturateDJNExemption is limited to test systems intended for 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, BarbiturateDLXExemption is limited to test systems intended for 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, BarbiturateDMFExemption is limited to test systems intended for 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, BarbiturateKZYExemption is limited to test systems intended for 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, BenzodiazepineJXMExemption is limited to test systems intended for 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, BenzodiazepineLAAExemption is limited to test systems intended for 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.).
862.3170Test, Benzodiazepine, Over The CounterNFVExemption is limited to test systems intended for 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, BenzodiazepineKZZExemption is limited to test systems intended for 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, BenzodiazepineLABExemption is limited to test systems intended for 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.).
862.3200Calibrators, Drug MixtureDKB
862.3200Calibrators, Drug SpecificDLJ
862.3200Calibrators, Ethyl AlcoholDNN
862.3250Enzyme Immunoassay, Cocaine and Cocaine MetabolitesDIOExemption is limited to test systems intended for 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 MetaboliteKLNExemption is limited to test systems intended for 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.).
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862.3250Enzyme Immunoassay, CocaineJXOExemption is limited to test systems intended for 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)DLNExemption is limited to test systems intended for 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, CocaineDMNExemption is limited to test systems intended for 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.).
862.3250Free Radical Assay, CocaineDIRExemption is limited to test systems intended for 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, CocaineDINExemption is limited to test systems intended for 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, BenzoylecgonineDOMExemption is limited to test systems intended for 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 MetabolitesLACExemption is limited to test systems intended for 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, CodeineLAEExemption is limited to test systems intended for 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, CodeineDLDExemption is limited to test systems intended for 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, CodeineLADExemption is limited to test systems intended for 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)DLBExemption is limited to test systems intended for 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.).
862.3580Free Radical Assay, LSDDOLExemption is limited to test systems intended for 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, MethamphetamineLAFExemption is limited to test systems intended for 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, MethamphetamineDJCExemption is limited to test systems intended for 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 13615
862.3610High Pressure Liquid Chromatography, MethamphetamineLAGExemption is limited to test systems intended for 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 CounterNGGExemption is limited to test systems intended for 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, MethadoneDJRExemption is limited to test systems intended for 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, MethadoneDIWExemption is limited to test systems intended for 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, MethadoneDMBExemption is limited to test systems intended for 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.).
862.3620Thin Layer Chromatography, MethadoneDKRExemption is limited to test systems intended for 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, MethadoneDNTExemption is limited to test systems intended for 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, MethadoneDPPExemption is limited to test systems intended for 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, MethaqualoneKXSExemption is limited to test systems intended for 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, MorphineDNKExemption is limited to test systems intended for 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.DOEExemption is limited to test systems intended for 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, MorphineDJJExemption is limited to test systems intended for 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, MorphineDPKExemption is limited to test systems intended for 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.).
862.3640Gas Chromatography, MorphineDMYExemption is limited to test systems intended for 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.).
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862.3640Hemagglutination Inhibition, MorphineDLRExemption is limited to test systems intended for 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, MorphineDOKExemption is limited to test systems intended for 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.DIQExemption is limited to test systems intended for 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 AntibodyDNAExemption is limited to test systems intended for 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, OpiatesDJGExemption is limited to test systems intended for 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, OpiatesDJFExemption is limited to test systems intended for 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, OpiatesDLTExemption is limited to test systems intended for 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.).
862.3650Thin Layer Chromatography, OpiatesLAIExemption is limited to test systems intended for 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, OpiatesDKTExemption is limited to test systems intended for 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, OpiatesLAHExemption is limited to test systems intended for 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, PropoxypheneJXNExemption is limited to test systems intended for 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, PropoxypheneDPNExemption is limited to test systems intended for 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, PropoxypheneLAJExemption is limited to test systems intended for 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, PropoxypheneLAKExemption is limited to test systems intended for 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 13617
862.3870Enzyme Immunoassay, CannabinoidsLDJExemption is limited to test systems intended for 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.).
862.3870Reagents, Test, TetrahydrocannabinolDKEExemption is limited to test systems intended for 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)LATExemption is limited to test systems intended for 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 DrugsLFIExemption is limited to test systems intended for 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 DrugsLFHExemption is limited to test systems intended for 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 DrugsMLKExemption is limited to test systems intended for 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.).
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
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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
866.5750System, Test, Radioallergosorbent (RAST) ImmunologicalDHBExemption is limited to devices classified under 21 CFR 866.5750 that are intended to detect any of the allergens included in table 2 of this document.
866.5910Quality Control Material, Genetics, DNANZB
868.1040Algesimeter, PoweredBSI
868.1400Legging, Compression, Non-InflatableLLK
868.2385Analyzer, Nitrogen DioxideMRQExemption 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.
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
870.1330Wire, Guide, CatheterDQXExemption is limited to accessory torque devices that are manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires.
870.1390TrocarDRC
870.1650Syringe, Balloon InflationMAVExemption is limited to non-patient contacting balloon inflation syringes intended only to inflate/deflate balloon catheters and monitor pressure within the balloon.
870.1875Lung Sound MonitorOCR
870.2675OscillometerDRZ
870.2770Analyzer, Body CompositionMNWExemption is limited to body composition analyzers which are not intended to diagnose or treat any medical condition.
870.4280Filter, Prebypass, Cardiopulmonary BypassKRJ
870.4290Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL
870.4340Monitor and/or Control, Level Sensing, Cardiopulmonary BypassDTW
870.4400Reservoir, Blood, Cardiopulmonary BypassDTNExemption is limited to cardiopulmonary bypass blood reservoirs that do not contain defoamers or blood filters.
870.4420Sucker, Cardiotomy Return, Cardiopulmonary BypassDTS
870.4430Suction Control, Intracardiac, Cardiopulmonary BypassDWD
872.1720Tester, PulpEAT
Start Printed Page 13619
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
872.3600Denture Preformed (Partially Prefabricated Denture)EKO
872.3890Splint, Endodontic StabilizingELS
872.5550Ring, Teething, Fluid-FilledKKO
872.6770Syringe, CartridgeEJI
874.1090Tester, Auditory ImpedanceETYExemption is limited to auditory impedance testers that are in compliance with FDA-recognized consensus standard ANSI S3.39.
874.1090TympanometerNASExemption is limited to tympanometers that are in compliance with FDA-recognized consensus standard ANSI S3.39.
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
876.1500Endoscopic Magnetic RetrieverFCCExemption is limited to endoscopic magnetic retrievers intended for single use.
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
876.1500Scissors For CystoscopeKGDExemption is limited to sterile scissors for cystoscope intended for single use.
876.1500LED Light SourceNTN
876.1500Endoscopic Guide Wire, Gastroenterology-UrologyOCY
876.1500Endoscopic Grasping/Cutting Instrument, Non-PoweredOCZExemption is limited to disposable, non-powered endoscopic grasping/cutting instruments intended for single use.
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
876.5010Catheter, Biliary, SurgicalGCAExemption is limited to surgical biliary catheters that do not include a balloon component.
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
876.5630Catheter, Peritoneal, Long-Term IndwellingFJSExemption is limited to non-patient contacting catheter finger grips intended for single use.
876.5630Catheter, Peritoneal Dialysis, Single UseFKOExemption is limited to non-patient contacting catheter finger grips intended for single use.
876.5630System, Peritoneal, Automatic DeliveryFKXExemption is limited to continuous ambulatory peritoneal dialysis (CAPD) belts and catheter stands that do not include weigh scales.
876.5665Disinfectant, Subsystem, Water PurificationNIH
876.5820Set, Dialyzer HolderFKI
876.5895Irrigator, OstomyEXD
Start Printed Page 13620
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
878.4370Drape, SurgicalKKXExemption is limited to surgical drapes that do not include an antimicrobial agent.
878.4495Suture, Nonabsorbable, Steel, Monofilament And Multifilament, SterileGAQExemption is limited to steel monofilament sutures that are uncoated and do not incorporate barbs.
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
882.1470Computerized Cognitive Assessment AidPKQExemption 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.
882.1540Device, Galvanic Skin Response MeasurementGZO
882.1560Device, Skin Potential MeasurementHCJ
882.1855Encephalogram Telemetry SystemGYE
882.5895Vibratory Counter-StimulationOVP
884.1630Colposcope (and Colpomicroscope)HEXExemption 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.
884.2990Sheet, Recording, Breast ExaminationNHM
884.3200Drain, CervicalHFL
884.4400Forceps, ObstetricalHDA
884.4530Tenaculum, UterineHDCExemption is limited to sterile urterine tenaculum devices that do not use suction and are intended for single use.
884.4530Clamp, UmbilicalHFW
884.4530Speculum, Vaginal, NonmetalHIB
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
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884.5425Pad, Menstrual, ScentedHHL
884.6120Accessory, Assisted ReproductionMQGExemption is limited to single 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)MQHExemption is limited to assisted reproduction microtools (pipettes) manufactured from glass.
884.6150Micromanipulators and Microinjectors, Assisted ReproductionMQJ
884.6160Labware, Assisted ReproductionMQKExemption is limited to dishes and plates that are intended for general assisted reproduction technology procedures.
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
886.1850Biomicroscope, Slit-Lamp, AC-PoweredHJOExemption 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.
886.1945Transilluminator, AC-PoweredHJM
886.3320Ocular PegMQUExemption is limited to ocular pegs supplied sterile.
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
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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

In table 1, FDA included devices classified under § 866.5750 (Radioallergosorbent (RAST) immunological test system, product code “DHB”). FDA does not believe that all devices with the product code DHB meet the exemption criteria from premarket notification requirements. However, FDA is identifying a substantial amount of these devices for exemption in table 2.

Table 2—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.
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.
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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.
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.
Start Printed Page 13624
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.
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.
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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.
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 sppPaecilomyces spp.
m25Aspergillus versicolorAspergillus versicolor.
m25Penicillium brevicompactumPenicillium brevicompactum.
m26Cladosporium cladosporioidesCladosporium cladosporioides.
m26Penicillium citrinumPenicillium citrinum.
m27Penicillium sppPenicillium 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.
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m67MycogoneMycogone perniciosa.
m68Nigrospora oryzaeNigrospora oryzae.
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 sppHelminthosporium 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.
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.
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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.
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.
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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.
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.).
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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.
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.
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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.
f382Beet, sugarBeta vulgaris var. altissima.
f401LoquatEriobotrya japonica.
f402FigFicus carica.
f403Brewer's yeastSaccharomyces cerevisiae.
f405MintMentha spp.
f406ArugulaEruca vesicaria.
House Dust
h1Greer Labs., IncNA.
h2Hollister-Stier LabsNA.
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.
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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.
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.).
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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.

V. Reference

The following reference is on display in the Division of Dockets Management (see ADDRESSES) 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: March 8, 2017.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2017-04938 Filed 3-13-17; 8:45 am]

BILLING CODE 4164-01-P