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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.


Immunology

Help
Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
866.5080 Alpha-1-antichymotrypsin immunological test system. II  
  DFF -  Alpha-1-Antichymotrypsin, Antigen, Antiserum, Control   Pilot  
866.5090 Antimitochondrial antibody immunological test system. II  
  DBM -  Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control   Pilot  
866.5100 Antinuclear antibody immunological test system. II  
PDF Guidance file for Antinuclear antibody immunological test system. (21CFR866.5100)  
  DHN -  Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control      
  KTL -  Anti-Dna Indirect Immunofluorescent Solid Phase      
  LJM -  Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls      
  LKJ -  Antinuclear Antibody, Antigen, Control      
  LKO -  Anti-Rnp Antibody, Antigen And Control      
  LKP -  Anti-Sm Antibody, Antigen And Control      
  LLL -  Extractable Antinuclear Antibody, Antigen And Control      
  LRM -  Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control      
  LSW -  Anti-Dna Antibody, Antigen And Control      
866.5120 Antismooth muscle antibody immunological test system. II  
  DBE -  Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control   Pilot  
866.5130 Alpha-1-antitrypsin immunological test system. II  
  DEI -  Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control   Pilot  
  DEM -  Alpha-1-Antitrypsin, Antigen, Antiserum, Control   Pilot  
  DFB -  Alpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control   Pilot  
866.5150 Bence-Jones proteins immunological test system. II  
  CZQ -  Bence-Jones Protein, Antigen, Antiserum, Control   Pilot  
  JKM -  Immunochemical, Bence-Jones Protein   Pilot  
866.5240 Complement components immunological test system. II  
  CZW -  Complement C3, Antigen, Antiserum, Control   Pilot  
  CZY -  Complement C1s, Antigen, Antiserum, Control   Pilot  
  DAE -  Complement C9, Antigen, Antiserum, Control   Pilot  
  DAG -  Complement C8, Antigen, Antiserum, Control   Pilot  
  DAI -  Complement C1r, Antigen, Antiserum, Control   Pilot  
  DAK -  Complement C1q, Antigen, Antiserum, Control   Pilot  
  DAY -  Complement C5, Antigen, Antiserum, Control   Pilot  
  DBI -  Complement C4, Antigen, Antiserum, Control   Pilot  
  KTM -  C3-Indirect Immunofluorescent Solid Phase   Pilot  
866.5250 Complement C2 inhibitor (inactivator) immunological test system. II  
  DBA -  Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control   Pilot  
866.5260 Complement C3b inactivator immunological test system. II  
  DAC -  Complement C3b Activator, Antigen, Antiserum, Control   Pilot  
  KTP -  Complement C3b Activator Immunoassay Reagents   Pilot  
866.5270 C-reactive protein immunological test system. II  
  DCH -  System, Test, C-Reactive Protein, Rhodamine      
  DCK -  C-Reactive Protein, Antigen, Antiserum, And Control      
  DCN -  System, Test, C-Reactive Protein      
866.5340 Ferritin immunological test system. II  
  JMG -  Radioimmunoassay (Two-Site Solid Phase), Ferritin   Pilot  
  DBF -  Ferritin, Antigen, Antiserum, Control   Pilot  
866.5350 Fibrinopeptide A immunological test system. II  
  DAN -  Fibrinopeptide A, Antigen, Antiserum, Control   Pilot  
866.5510 Immunoglobulins A, G, M, D, and E immunological test system. II  
  HTML Guidance file for Immunoglobulins A, G, M, D, and E immunological test system. (21CFR866.5510)
  CFF -  Immunoelectrophoretic, Immunoglobulins, (G, A, M)   Pilot  
  CFN -  Method, Nephelometric, Immunoglobulins (G, A, M)   Pilot  
  CFQ -  Radioimmunoassay, Immunoglobulins (G, A, M)   Pilot  
  CGM -  Method, Immunodiffusion, Immunoglobulins (G, A, M)   Pilot  
  CZJ -  Igd, Antigen, Antiserum, Control      
  CZK -  Iga, Rhodamine, Antigen, Antiserum, Control      
  CZL -  Iga, Peroxidase, Antigen, Antiserum, Control      
  CZM -  Iga, Ferritin, Antigen, Antiserum, Control      
  CZN -  Iga, Fitc, Antigen, Antiserum, Control      
  CZP -  Iga, Antigen, Antiserum, Control      
  DAA -  Igg, Peroxidase, Antigen, Antiserum, Control      
  DAF -  Gamma Globulin, Fitc, Antigen, Antiserum, Control      
  DAH -  Gamma Globulin, Antigen, Antiserum, Control      
  DEW -  Igg, Antigen, Antiserum, Control      
  DFM -  Ige, Ferritin, Antigen, Antiserum, Control      
  DFO -  Igg, Rhodamine, Antigen, Antiserum, Control      
  DFZ -  Igg (Gamma Chain Specific), Antigen, Antiserum, Control      
  DGC -  Ige, Antigen, Antiserum, Control      
  DGD -  Igg, Ferritin, Antigen, Antiserum, Control      
  DGE -  Igd, Rhodamine, Antigen, Antiserum, Control      
  DGG -  Igd, Fitc, Antigen, Antiserum, Control      
  DGH -  Igd, Peroxidase, Antigen, Antiserum, Control      
  DGK -  Igg, Fitc, Antigen, Antiserum, Control      
  DGL -  Ige, Rhodamine, Antigen, Antiserum, Control      
  DGO -  Ige, Peroxidase, Antigen, Antiserum, Control      
  DGP -  Ige, Fitc, Antigen, Antiserum, Control      
  JHR -  Radioimmunoassay, Immunoglobulins (D, E)   Pilot  
  KTS -  Second Antibody (Species Specific Anti-Animal Gamma Globulin)   Pilot  
  MLH -  Strip, Hama Igg, Elisa, In Vitro Test System   Pilot  
866.5550 Immunoglobulin (light chain specific) immunological test system. II  
  DAO -  Igm (Mu Chain Specific), Antigen, Antiserum, Control   Pilot  
  DEH -  Lambda, Antigen, Antiserum, Control   Pilot  
  DEK -  Kappa, Rhodamine, Antigen, Antiserum, Control   Pilot  
  DEO -  Kappa, Fitc, Antigen, Antiserum, Control   Pilot  
  DEP -  Lambda, Peroxidase, Antigen, Antiserum, Control   Pilot  
  DES -  Lambda, Fitc, Antigen, Antiserum, Control   Pilot  
  DEY -  Igm, Peroxidase, Antigen, Antiserum, Control   Pilot  
  DEZ -  Igm, Rhodamine, Antigen, Antiserum, Control   Pilot  
  DFD -  Kappa, Peroxidase, Antigen, Antiserum, Control   Pilot  
  DFG -  Lambda, Rhodamine, Antigen, Antiserum, Control   Pilot  
  DFH -  Kappa, Antigen, Antiserum, Control   Pilot  
  DFL -  Igm, Ferritin, Antigen, Antiserum, Control   Pilot  
  DFS -  Igm, Fitc, Antigen, Antiserum, Control   Pilot  
  DFT -  Igm, Antigen, Antiserum, Control   Pilot  
  LYE -  Cytokeratins   Pilot  
866.5580 Alpha-1-lipoprotein immunological test system. II  
  DER -  Alpha-1-Lipoprotein, Antigen, Antiserum, Control   Pilot  
866.5600 Low-density lipoprotein immunological test system. II  
  DFC -  Lipoprotein, Low-Density, Antigen, Antiserum, Control   Pilot  
866.5620 Alpha-2-macroglobulin immunological test system. II  
  DDT -  Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control   Pilot  
  DDY -  Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control   Pilot  
  DEB -  Alpha-2-Macroglobulin, Antigen, Antiserum, Control   Pilot  
866.5630 Beta-2-microglobulin immunological test system. II  
  JZG -  System, Test, Beta-2-Microglobulin Immunological   Pilot  
866.5640 Infectious mononucleosis immunological test system. II  
  KTN -  System, Test, Infectious Mononucleosis   Pilot  
866.5680 Myoglobin immunological test system. II  
  DDO -  Myoglobin, Rhodamine, Antigen, Antiserum, Control   Pilot  
  DDR -  Myoglobin, Antigen, Antiserum, Control   Pilot  
  DEA -  Myoglobin, Fitc, Antigen, Antiserum, Control   Pilot  
  MVE -  Biosensor,Immunoassay,Myoglobin   Pilot  
866.5775 Rheumatoid factor immunological test system. II  
PDF Guidance file for Rheumatoid factor immunological test system. (21CFR866.5775)  
  DHR -  System, Test, Rheumatoid Factor      
866.5820 Systemic lupus erythematosus immunological test system. II  
  DHC -  System, Test, Systemic Lupus Erythematosus   Pilot  
866.5870 Thyroid autoantibody immunological test system. II  
  JNL -  Immunochemical, Thyroglobulin Autoantibody      
  JZO -  System, Test, Thyroid Autoantibody      
866.5880 Transferrin immunological test system. II  
  DDD -  Transferrin, Rhodamine, Antigen, Antiserum, Control   Pilot  
  DDG -  Transferrin, Antigen, Antiserum, Control   Pilot  
  DDI -  Transferrin, Fitc, Antigen, Antiserum, Control   Pilot  
  JNM -  Immunochemical, Transferrin   Pilot  

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