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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 May 29, 2023

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.


Hematology
help
Section No. Regulation Name
Product Code-Device Name		 Class
Available
Standards
864.1860 Immunohistochemistry reagents and kits. II  
  MXZ -  Immunohistochemistry Assay, Antibody, Progesterone Receptor  
  MYA -  Immunohistochemistry Antibody Assay, Estrogen Receptor  
  NJW -  Control Material, Her-2/Neu, Immunohistochemistry  
864.1870 Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization. II  
  PDO -  Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization  
  PFG -  Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders  
864.5200 Automated cell counter. II  
  GKL -  Counter, Cell, Automated (Particle Counter)  
  GKX -  Instrument, Automated Platelet Counting  
  LKM -  Counter, Urine Particle  
864.5220 Automated differential cell counter. II  
  MAM -  Dna-Probe, B And T Lymphocyte  
  OYE -  Flow Cytometric Reagents And Accessories.  
  PMG -  Automated Multicolor Fluorescent Imaging Cytometric Analysis System  
  POV -  Semen Analysis Device  
  LIZ -  Assay, T Lymphocyte Surface Marker  
  LJD -  Assay, B Lymphocyte Marker  
  NID -  Assay, Proliferation, In Vitro, T Lymphocyte  
  PDX -  Flow Cytometry Calibrator  
864.5260 Automated cell-locating device. II  
  JOY -  Device, Automated Cell-Locating  
864.5300 Red cell indices device. II  
  JBW -  Red-Cell Indices, Measured  
  JPJ -  Red-Cell Indices, Calculated  
  KQH -  Red-Cell Indices  
864.5400 Coagulation instrument. II  
  GKN -  Timer, Clot, Automated  
  GKP -  Instrument, Coagulation, Automated  
  KQG -  Instrument, Coagulation  
864.5425 Multipurpose system for in vitro coagulation studies. II  
  JPA -  System, Multipurpose For In Vitro Coagulation Studies  
  LGP -  Assay, Alpha-2-Antiplasmin  
  LLG -  Kit, Igg, Platelet Associated  
864.5680 Automated heparin analyzer. II  
  JOX -  Analyzer, Heparin, Automated  
864.5700 Automated platelet aggregation system. II  
  GHR -  Reagent, Platelet Aggregation  
  JOZ -  System, Automated Platelet Aggregation  
  OBW -  11-Dehydro Thromboxane B2 Kit, Urinary  
864.5950 Blood volume measuring device. II  
  JWO -  Device, Blood Volume Measuring  
864.6550 Occult blood test. II  
  GGG -  Guaiac Reagent  
  JIO -  Blood, Occult, Colorimetric, In Urine  
  JIP -  Blood, Occult, Enzymatic Method, In Urine  
  KHE -  Reagent, Occult Blood  
  OOX -  Automated Occult Blood Analyzer  
  NGK -  Test, Occult Blood, Over The Counter  
864.6675 Platelet aggregometer. II  
  GKW -  Aggregometer, Platelet, Thrombokinetogram  
  JBX -  Aggregrometer, Platelet  
  JBY -  Aggregometer, Platelet, Photo-Optical Scanning  
864.7010 Flow cytometric test system for hematopoietic neoplasms. II  
  PWD -  Flow Cytometric Test System For Hematopoietic Neoplasms  
864.7060 Antithrombin III assay. II  
  DDQ -  Antigen, Antiserum, Control, Antithrombin Iii  
  JBQ -  Antithrombin Iii Quantitation  
  JPE -  Antithrombin Iii, Two Stage Clotting Time Assay  
864.7100 Red blood cell enzyme assay. II  
  JBE -  Cell Enzymes (Erythrocytic And Leukocytic)  
  LKZ -  Red-Cell Count By Photometry  
864.7140 Activated whole blood clotting time tests. II  
  JBP -  Activated Whole Blood Clotting Time  
864.7250 Erythropoietin assay. II  
  GGT -  Assay, Erythropoietin  
864.7280 Factor V Leiden DNA mutation detection systems. II  
  OMM -  Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr  
864.7290 Factor deficiency test. II  
  GGP -  Test, Qualitative And Quantitative Factor Deficiency  
  GJT -  Plasma, Coagulation Factor Deficient  
864.7320 Fibrinogen/fibrin degradation products assay. II  
  DAP -  Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control  
  GHH -  Fibrin Split Products  
  MIF -  Prothrombin Fragment 1.2  
864.7340 Fibrinogen determination system. II  
  DAR -  Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control  
  DAT -  Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control  
  DAX -  Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control  
  DAZ -  Fibrinogen And Split Products, Antigen, Antiserum, Control  
  GFK -  Fibrinogen Determination Standards And Controls  
  GIS -  Test, Fibrinogen  
  KQJ -  System, Fibrinogen Determination  
864.7360 Erythrocytic glucose-6-phosphate dehydrogenase assay. II  
  JBF -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening  
  JBG -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot  
  JBH -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod  
  JBI -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition  
  JBJ -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction  
  JBK -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic  
  JBL -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative  
  JBM -  Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis  
  JLM -  Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase  
  JMB -  Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase  
  JMC -  Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase  
  KQE -  Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase  
864.7400 Hemoglobin A2 assay. II  
  JPD -  Hemoglobin A2 Quantitation  
864.7415 Abnormal hemoglobin assay. II  
  GIQ -  Hemoglobin S  
  GKA -  Abnormal Hemoglobin Quantitation  
  JPB -  Hemoglobin M  
  MLL -  Hemoglobin C (Abnormal Hemoglobin Variant)  
864.7425 Carboxyhemoglobin assay. II  
  GHS -  Assay, Carboxyhemoglobin  
864.7440 Electrophoretic hemoglobin analysis system. II  
  JBD -  System, Analysis, Electrophoretic Hemoglobin  
864.7455 Fetal hemoglobin assay. II  
  GHA -  Hemoglobin, Alkali Resistant  
  JPC -  Hemoglobin F Quantitation  
  KQI -  Assay, Fetal Hemoglobin  
864.7490 Sulfhemoglobin assay. II  
  GJC -  Assay, Sulfhemoglobin  
864.7500 Whole blood hemoglobin assays. II  
  GGZ -  Oxyhemoglobin  
  GIG -  Hemoglobinometer  
  GJZ -  Cyanomethemoglobin Reagent And Standard Solution  
  GKK -  Cyanomethemoglobin  
  GLY -  Oximeter To Measure Hemoglobin  
  KHG -  Whole Blood Hemoglobin Determination  
  LGL -  Assay, Bart'S, Hemoglobin  
864.7525 Heparin assay. II  
  GFT -  Protamine Sulphate  
  JBR -  Test, Heparin Neutralization  
  KFF -  Assay, Heparin  
864.7695 Platelet factor 4 radioimmunoassay. II  
  LCO -  Platelet Factor 4 Radioimmunoassay  
864.7750 Prothrombin time test. II  
  ODV -  Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System  
864.7825 Sickle cell test. II  
  GHM -  Test, Sickle Cell  
  JBB -  Solubility, Hemoglobin, Abnormal  
864.7875 Thrombin time test. II  
  GJA -  Test, Thrombin Time  
  GJB -  Thrombin  
864.7925 Partial thromboplastin time tests. II  
  GFO -  Activated Partial Thromboplastin  
  GGO -  Reagent, Thromboplastin And Control  
  GGW -  Test, Time, Partial Thromboplastin  
  GIT -  Reagent & Control, Partial Thromboplastin Time  
864.8100 Bothrops atrox reagent. II  
  JCO -  Bothrops Atrox Reagent  
864.8950 Russell viper venom reagent. I  
  GIR -  Reagent, Russel Viper Venom  
864.9650 Quality control kit for blood banking reagents. II  
  PFK -  Quality Control For Molecular Immunohematology Tests  

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