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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated: February 7, 2002

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This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that FDA has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


Microbiology

Help
Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
866.1620 ANTIMICROBIAL SUSCEPTIBILITY TEST DISC II  
  HTML Guidance file for ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (21CFR866.1620)
  JTN -  Susceptibility Test Discs, Antimicrobial      
  LTX -  Discs, Elution      
866.1640 ANTIMICROBIAL SUSCEPTIBILITY TEST POWDER II  
PDF Guidance file for ANTIMICROBIAL SUSCEPTIBILITY TEST POWDER (21CFR866.1640)  
  JTT -  Susceptibility Test Powders, Antimicrobial      
  JWY -  Manual Antimicrobial Susceptibility Test Systems      
  LIE -  Reagent/Device, Inoculum Calibration      
  LOP -  Solution, Antimicrobial      
  LRG -  Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems      
  LTT -  Panels, Test, Susceptibility, Antimicrobial      
  LTW -  Susceptibility Test Cards, Antimicrobial      
866.1700 CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTS II  
  JTZ -  Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth   Pilot  
  LKA -  Culture Media, Antimicrobial Susceptibility Test   Pilot  
  MJE -  Culture Media, Antifungal, Susceptibility Test   Pilot  
866.2390 TRANSPORT CULTURE MEDIUM I  
 General Guidance
  JSL -  Culture Media, Anaerobic Transport      
  JSM -  Culture Media, Non-Propagating Transport      
  JSN -  Culture Media, Propagating Transport      
866.2560 MICROBIAL GROWTH MONITOR I  
  HTML Guidance file for MICROBIAL GROWTH MONITOR (21CFR866.2560)
  MDB -  System, Blood Culturing      
866.2850 AUTOMATED ZONE READER I  
 General Guidance
  KZK -  Reader, Zone, Automated      
866.2900 MICROBIOLOGICAL SPECIMEN COLLECTION AND TRANSPORT DEVICE I  
 General Guidance
  JTW -  System, Transport, Aerobic      
  JTX -  Transport Systems, Anaerobic      
  LIO -  Device, Specimen Collection      
  LKS -  Device, Parasite Concentration      
866.3110 CAMPYLOBACTER FETUS SEROLOGICAL REAGENTS I  
  HTML Guidance file for CAMPYLOBACTER FETUS SEROLOGICAL REAGENTS (21CFR866.3110)
  GSP -  Antiserum, Fluorescent, Campylobacter Fetus      
  LQO -  Dna-Reagents, Campylobacter Spp.      
  LQP -  Campylobacter Spp.      
  LYR -  Helicobacter Pylori      
  MSQ -  Test, Urea (Breath Or Blood)      
866.3120 CHLAMYDIA SEROLOGICAL REAGENTS I  
 General Guidance
  GPT -  Antiserum, Cf, Psittacosis (Chlamydia Group)      
  GPW -  Antigen, Cf, Psittacosis (Chlamydia Group)      
  LJC -  Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)      
  LJP -  Antiserum, Fluorescent, Chlamydia Trachomatis      
  LKH -  Antisera, Immunoperoxidase, Chlamydia Spp.      
  LKI -  Antisera, Fluorescent, Chlamydia Spp.      
  LSK -  Dna-Reagents, Chlamydia      
  MGM -  C. Trachomatis (Chlamydia Group)      
  MKZ -  Dna Probe, Nucleic Acid Amplification, Chlamydia      
866.3175 CYTOMEGALOVIRUS SEROLOGICAL REAGENTS II  
  GQH -  Antigen, Cf (Including Cf Control), Cytomegalovirus   Pilot  
  GQI -  Antiserum, Cf, Cytomegalovirus   Pilot  
  LFZ -  Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus   Pilot  
  LIN -  Antisera, Conjugated Fluorescent, Cytomegalovirus   Pilot  
  LJO -  Antigen, Iha, Cytomegalovirus   Pilot  
  LKQ -  Antibody Igm,If, Cytomegalovirus Virus   Pilot  
866.3235 EPSTEIN-BARR VIRUS SEROLOGICAL REAGENTS I  
 General Guidance
  GNP -  Antiserum, Cf, Epstein-Barr Virus      
  GNQ -  Antigen, Cf (Including Cf Control), Epstein-Barr Virus      
  JRY -  Antiserum, Fluorescent, Epstein-Barr Virus      
  LJN -  Antibody Igm, If, Epstein-Barr Virus      
  LLM -  Test, Antigen, Nuclear, Epstein-Barr Virus      
  LSE -  Epstein-Barr Virus, Other      
  LSF -  Dna-Reagents, Epstein-Barr Virus      
  MCD -  Antigen, Ebv, Capsid      
866.3370 MYCOBACTERIUM TUBERCULOSIS IMMUNOFLUORESCENT REAGENTS I  
  HTML Guidance file for MYCOBACTERIUM TUBERCULOSIS IMMUNOFLUORESCENT REAGENTS (21CFR866.3370)
  GRT -  Antiserum, Fluorescent, Mycobacterium Tuberculosis      
  LQF -  Dna-Reagents, Mycobacterium Spp.      
  NDZ -  Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis      
866.3390 NEISSERA SPP. DIRECT SEROLOGICAL TEST REAGENTS II  
  GTH -  Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae   Pilot  
  GTI -  Antisera, Fluorescent, All Groups, N. Meningitidis   Pilot  
  GTJ -  Antisera, All Groups, N. Meningitidis   Pilot  
  LIC -  Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae   Pilot  
  LIR -  Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae   Pilot  
866.3510 RUBELLA VIRUS SEROLOGICAL REAGENTS II  
  GOJ -  Antisera, Neutralization, Rubella   Pilot  
  GOK -  Antisera, Hai (Including Hai Control), Rubella   Pilot  
  GOL -  Antigen, Ha (Including Ha Control), Rubella   Pilot  
  GOM -  Antisera, Cf, Rubella   Pilot  
  GON -  Antigen, Cf (Including Cf Control), Rubella   Pilot  
  LFX -  Enzyme Linked Immunoabsorbent Assay, Rubella   Pilot  
  LQN -  Latex Agglutination Assay, Rubella   Pilot  
  LSD -  Rubella, Other Assays   Pilot  
  LSJ -  Antigen, Rubella, Other   Pilot  
866.3780 TOXOPLASMA GONDII SEROLOGICAL REAGENTS II  
  GLZ -  Antigens, If, Toxoplasma Gondii   Pilot  
  GMM -  Antigens, Iha, Toxoplasma Gondii   Pilot  
  GMN -  Antigens, Cf, Toxoplasma Gondii   Pilot  
  LGD -  Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii   Pilot  
  LJK -  Antisera, If, Toxoplasma Gondii   Pilot  
  LLA -  Direct Agglutination Test, Toxoplasma Gondii   Pilot  
866.3820 TREPONEMA PALLIDUM NONTREPONEMAL TEST REAGENTS II  
  GMP -  Antisera, Control For Nontreponemal Tests   Pilot  
  GMQ -  Antigens, Nontreponemal, All   Pilot  
866.3830 TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS II  
  MYR -  Test,Donor,Syphilis,Antigens,Treponemal   Pilot  
  GMR -  Sera, Reactive And Non-Specific Control, Fta-Abs Test   Pilot  
  GMS -  Anti-Human Globulin, Fta-Abs Test   Pilot  
  GMT -  Antigens, Ha, Treponema Pallidum   Pilot  
  GMW -  Test, Sorbent, Fta-Abs   Pilot  
  GMX -  Antisera, Fluorescent Antibody For Fta-Abs Test   Pilot  
  JWL -  Antigen, Treponema Pallidum For Fta-Abs Test   Pilot  
866.3870 TRYPANOSOMA SPP. SEROLOGICAL REAGENTS I  
 General Guidance
  GND -  Antigen, Iha, T. Cruzi      
  GNE -  Antigen, Latex Agglutination, T. Cruzi      
  GNF -  Antigen, Cf, T. Cruzi      
  MIU -  Enzyme Linked Immunosorbent Assay, T. Cruzi      
  MIV -  Immunofluorescent Assay, T. Cruzi      
866.3900 VARICELLA-ZOSTER VIRUS SEROLOGICAL REAGENTS II  
  GQW -  Antigen, Cf, (Including Cf Control), Varicella-Zoster   Pilot  
  GQX -  Antiserum, Cf, Varicella-Zoster   Pilot  
  LFY -  Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster   Pilot  

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