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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 November 22, 2021

This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.

How to use the list of eligible devices

The list has four 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 provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.

Some important exceptions to the list

Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.


Microbiology

help
Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
866.1620 Antimicrobial susceptibility test disc. II  
  JTN -  Susceptibility Test Discs, Antimicrobial  
  LTX -  Discs, Elution  
866.1640 Antimicrobial susceptibility test powder. II  
  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  
  MYI -  System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies  
866.1700 Culture medium for antimicrobial susceptibility tests. II  
  JSO -  Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar  
  JTZ -  Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth  
  LKA -  Culture Media, Antimicrobial Susceptibility Test  
  MJD -  Culture Media, Antimycobacteria, Susceptibility Test  
  MJE -  Culture Media, Antifungal, Susceptibility Test  
866.2050 Staphylococcal typing bacteriophage. I  
  OUS -  Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt  
866.2190 Automated image assessment system for microbial colonies on solid culture media. II  
  PPU -  Microbial Colony Image Assessment System  
866.2360 Selective culture medium. I  
  PQZ -  Gbs Culture Media, Selective And Differential  
866.2390 Transport culture medium. I  
  JSL -  Culture Media, Anaerobic Transport  
  JSM -  Culture Media, Non-Propagating Transport  
  JSN -  Culture Media, Propagating Transport  
866.2410 Culture medium for pathogenic Neisseria spp. II  
  JTY -  Culture Media, For Isolation Of Pathogenic Neisseria  
866.2560 Microbial growth monitor. I  
  MDB -  System, Blood Culturing  
866.2850 Automated zone reader. I  
  KZK -  Reader, Zone, Automated  
866.2900 Microbiological specimen collection and transport device. I  
  JTW -  System, Transport, Aerobic  
  JTX -  Transport Systems, Anaerobic  
  LIO -  Device, Specimen Collection  
866.3040 Aspergillus spp. serological reagents. I  
  NOM -  Antigen, Galactomannan, Aspergillus Spp.  
866.3110 Campylobacter fetus serological reagents. I  
  GSP -  Antiserum, Fluorescent, Campylobacter Fetus  
  LQO -  Dna-Reagents, Campylobacter Spp.  
  LQP -  Campylobacter Spp.  
  LYR -  Helicobacter Pylori  
  MSQ -  Test, Urea (Breath Or Blood)  
  OWF -  Immunohistochemical Assay, Helicobacter Pylori  
866.3120 Chlamydia serological reagents. I  
  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  
  GQI -  Antiserum, Cf, Cytomegalovirus  
  LIN -  Antisera, Conjugated Fluorescent, Cytomegalovirus  
  LJO -  Antigen, Iha, Cytomegalovirus  
  LKQ -  Antibody Igm,If, Cytomegalovirus Virus  
  LSO -  Dna-Reagents, Cytomegalovirus  
866.3235 Epstein-Barr virus serological reagents. I  
  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  
866.3330 Influenza virus serological reagents. I  
  NIA -  Assay, Direct, Nucleic Acid Amplification, Influenza Virus  
866.3370 Mycobacterium tuberculosis immunofluorescent reagents. I  
  GRT -  Antiserum, Fluorescent, Mycobacterium Tuberculosis  
  LQF -  Dna-Reagents, Mycobacterium Spp.  
  NDZ -  Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis  
  NJO -  System, Mycolic Acid Analysis, Mycobacterium Tuberculosis  
866.3390 Neisseria spp. direct serological test reagents. II  
  GTH -  Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae  
  GTI -  Antisera, Fluorescent, All Groups, N. Meningitidis  
  GTJ -  Antisera, All Groups, N. Meningitidis  
  LIC -  Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae  
  LIR -  Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae  
866.3400 Parainfluenza virus serological reagents. I  
  NHZ -  Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus  
866.3480 Respiratory syncytial virus serological reagents. I  
  NHY -  Assay, Direct, Nucleic Acid Amplification, Respiratory Syncytial Virus  
866.3510 Rubella virus serological reagents. II  
  GOJ -  Antisera, Neutralization, Rubella  
  GOK -  Antisera, Hai (Including Hai Control), Rubella  
  GOL -  Antigen, Ha (Including Ha Control), Rubella  
  GOM -  Antisera, Cf, Rubella  
  GON -  Antigen, Cf (Including Cf Control), Rubella  
  LFX -  Enzyme Linked Immunoabsorbent Assay, Rubella  
  LQN -  Latex Agglutination Assay, Rubella  
  LSD -  Rubella, Other Assays  
  LSJ -  Antigen, Rubella, Other  
  OPL -  Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus  
866.3780 Toxoplasma gondii serological reagents. II  
  GLZ -  Antigens, If, Toxoplasma Gondii  
  GMM -  Antigens, Iha, Toxoplasma Gondii  
  GMN -  Antigens, Cf, Toxoplasma Gondii  
  LGD -  Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii  
  LJK -  Antisera, If, Toxoplasma Gondii  
  LLA -  Direct Agglutination Test, Toxoplasma Gondii  
  LYF -  Pneumocystis Carinii  
866.3820 Treponema pallidum nontreponemal test reagents. II  
  GMP -  Antisera, Control For Nontreponemal Tests  
  GMQ -  Antigens, Nontreponemal, All  
866.3830 Treponema pallidum treponemal test reagents. II  
  GMR -  Sera, Reactive And Non-Specific Control, Fta-Abs Test  
  GMS -  Anti-Human Globulin, Fta-Abs Test  
  GMT -  Antigens, Ha, Treponema Pallidum  
  GMW -  Test, Sorbent, Fta-Abs  
  GMX -  Antisera, Fluorescent Antibody For Fta-Abs Test  
  JWL -  Antigen, Treponema Pallidum For Fta-Abs Test  
866.3870 Trypanosoma spp. serological reagents. I  
  GND -  Antigen, Iha, T. Cruzi  
  GNE -  Antigen, Latex Agglutination, T. Cruzi  
  GNF -  Antigen, Cf, T. Cruzi  
  LOO -  Reagent, Leishmanii Serological  
  MIU -  Enzyme Linked Immunosorbent Assay, T. Cruzi  
  MIV -  Immunofluorescent Assay, T. Cruzi  
  PIT -  Leishmania Spp. Antigen Detection Assay  
866.3900 Varicella-zoster virus serological reagents. II  
  GQW -  Antigen, Cf, (Including Cf Control), Varicella-Zoster  
  GQX -  Antiserum, Cf, Varicella-Zoster  
  LFY -  Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster  
866.3920 Assayed quality control material for clinical microbiology assays. II  
  PMN -  Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays  

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