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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.


Hematology

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Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
864.1860 Immunohistochemistry reagents and kits. II  
PDF Guidance file for Immunohistochemistry reagents and kits. (21CFR864.1860)  
  MXZ -  Immunohistochemistry Assay,Antibody,Progesterone Receptor      
  MYA -  Immunohistochemistry Antibody Assay, Estrogen Receptor      
  NBK -  System,Test,(Ihc),Tumor Marker,Monitoring,Bladder Cancer      
864.5260 Automated cell-locating device. II  
  JOY -  Device, Automated Cell-Locating   Pilot  
  LNJ -  Analyzer, Chromosome, Automated   Pilot  
864.5300 Red cell indices device. II  
  JBW -  Red-Cell Indices, Measured   Pilot  
  JPJ -  Red-Cell Indices, Calculated   Pilot  
  KQH -  Red-Cell Indices   Pilot  
864.5425 Multipurpose system for in vitro coagulation studies. II  
PDF Guidance file for Multipurpose system for in vitro coagulation studies. (21CFR864.5425)  
  JPA -  System, Multipurpose For In Vitro Coagulation Studies      
864.5600 Automated hematocrit instrument. II  
  GKF -  Instrument, Hematocrit, Automated   Pilot  
864.5620 Automated hemoglobin system. II  
  GKR -  System, Hemoglobin, Automated   Pilot  
864.5950 Blood volume measuring device. II  
  JWO -  Device, Blood Volume Measuring   Pilot  
864.6550 Occult blood test. II  
PDF Guidance file for Occult blood test. (21CFR864.6550)  
  GGG -  Guaiac Reagent      
  JIO -  Blood, Occult, Colorimetric, In Urine      
  JIP -  Blood, Occult, Enzymatic Method, In Urine      
  KHE -  Reagent, Occult Blood      
864.7040 Adenosine triphosphate release assay. I  
 General Guidance
  JWR -  Atp Release (Luminescence)      
  KHF -  Adenine Nucleotide Quantitation      
864.7100 Red blood cell enzyme assay. II  
  JBE -  Cell Enzymes (Erythrocytic And Leukocytic)   Pilot  
  LKZ -  Red-Cell Count By Photometry   Pilot  
864.7250 Erythropoietin assay. II  
 
  GGT -  Assay, Erythropoietin      
864.7275 Euglobulin lysis time tests. II  
  JBO -  Test, Euglobulin Lysis   Pilot  
864.7300 Fibrin monomer paracoagulation test. II  
PDF Guidance file for Fibrin monomer paracoagulation test. (21CFR864.7300)  
  JBN -  Fibrin Monomer Paracoagulation      
864.7320 Fibrinogen/fibrin degradation products assay. II  
  DAP -  Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control   Pilot  
  GHH -  Fibrin Split Products   Pilot  
  MIF -  Prothrombin Fragment 1.2   Pilot  
864.7340 Fibrinogen determination system. II  
PDF Guidance file for Fibrinogen determination system. (21CFR864.7340)  
  GFK -  Fibrinogen Determination Standards And Controls   Pilot  
  GFX -  Fibrinogen Standard      
  GIL -  Plasma, Fibrinogen Control   Pilot  
  GIS -  Test, Fibrinogen   Pilot  
  KQJ -  System, Fibrinogen Determination   Pilot  
864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay. II  
  JBF -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening   Pilot  
  JBG -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot   Pilot  
  JBH -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod   Pilot  
  JBI -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition   Pilot  
  JBJ -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction   Pilot  
  JBK -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic   Pilot  
  JBL -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative   Pilot  
  JBM -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis   Pilot  
  JLM -  Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase   Pilot  
  JMB -  Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase   Pilot  
  JMC -  Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase   Pilot  
  KQE -  Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase   Pilot  
864.7375 Glutathione reductase assay. II  
  GII -  Glutathione, Red-Cell   Pilot  
  JMH -  Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase   Pilot  
  KQF -  Assay, Glutathione Reductase   Pilot  
864.7400 Hemoglobin A2assay. II  
  JPD -  Hemoglobin A2 Quantitation   Pilot  
864.7415 Abnormal hemoglobin assay. II  
  GIQ -  Hemoglobin S   Pilot  
  GKA -  Abnormal Hemoglobin Quantitation   Pilot  
  JCM -  Control, Hemoglobin, Abnormal   Pilot  
  JPB -  Hemoglobin M   Pilot  
  MLL -  Hemoglobin C (Abnormal Hemoglobin Variant)   Pilot  
864.7425 Carboxyhemoglobin assay. II  
  GHS -  Assay, Carboxyhemoglobin   Pilot  
864.7440 Electrophoretic hemoglobin analysis system. II  
  JBD -  System, Analysis, Electrophoretic Hemoglobin   Pilot  
864.7455 Fetal hemoglobin assay. II  
  GHA -  Hemoglobin, Alkali Resistant   Pilot  
  GHQ -  Stain, Fetal Hemoglobin   Pilot  
  JPC -  Hemoglobin F Quantitation   Pilot  
  KQI -  Assay, Fetal Hemoglobin   Pilot  
  LIM -  Test, Screening, For D Positive Fetal Rbc'S   Pilot  
864.7470 Glycosylated hemoglobin assay. II  
PDF Guidance file for Glycosylated hemoglobin assay. (21CFR864.7470)  
  LCP -  Assay, Glycosylated Hemoglobin      
864.7490 Sulfhemoglobin assay. II  
  GJC -  Assay, Sulfhemoglobin   Pilot  
864.7500 Whole blood hemoglobin assays. II  
PDF Guidance file for Whole blood hemoglobin assays. (21CFR864.7500)  
  GGF -  Acid Hematin   Pilot  
  GGZ -  Oxyhemoglobin   Pilot  
  GIG -  Hemoglobinometer   Pilot  
  GJZ -  Cyanomethemoglobin Reagent And Standard Solution      
  GKK -  Cyanomethemoglobin   Pilot  
  GLY -  Oximeter To Measure Hemoglobin   Pilot  
  KHG -  Whole Blood Hemoglobin Determination   Pilot  
  LGL -  Assay, Bart'S, Hemoglobin   Pilot  
864.7825 Sickle cell test. II  
  GHM -  Test, Sickle Cell   Pilot  
  JBB -  Solubility, Hemoglobin, Abnormal   Pilot  
864.8100 Bothrops atrox reagent. II  
  JCO -  Bothrops Atrox Reagent   Pilot  
864.8150 Calibrator for cell indices. II  
PDF Guidance file for Calibrator for cell indices. (21CFR864.8150)  
  KRX -  Calibrator For Cell Indices      
864.8165 Calibrator for hemoglobin or hematocrit measurement. II  
PDF Guidance file for Calibrator for hemoglobin or hematocrit measurement. (21CFR864.8165)  
  KRZ -  Calibrator For Hemoglobin And Hematocrit Measurement      
864.8175 Calibrator for platelet counting. II  
PDF Guidance file for Calibrator for platelet counting. (21CFR864.8175)  
  KRY -  Calibrator For Platelet Counting      
864.8185 Calibrator for red cell and white cell counting. II  
PDF Guidance file for Calibrator for red cell and white cell counting. (21CFR864.8185)  
  KSA -  Calibrator For Red-Cell And White-Cell Counting      
864.8625 Hematology quality control mixture. II  
 
  GFS -  Standards And Controls, Hemoglobin, Normal And Abnormal      
  GGL -  Control, White-Cell      
  GGM -  Control, Hemoglobin      
  GJP -  Control, Platelet      
  GJR -  Control, Red-Cell      
  GLK -  Control, Hematocrit      
  GLQ -  Mixture, Control, White-Cell And Red-Cell Indices      
  JCN -  Control, Cell Counter, Normal And Abnormal      
  JPK -  Mixture, Hematology Quality Control      
864.8950 Russell viper venom reagent. I  
 General Guidance
  GIR -  Reagent, Russel Viper Venom      

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