Part 864 Subpart H—Hematology Kits and Packages
FDA submissions for Part 864 Subpart H—Hematology Kits and Packages in the Hematology (HE) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 864.7010–864.7925
CFR Part: 864
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| PWD | Flow Cytometric Test System For Hematopoietic Neoplasms | 864.7010 | 2 | 2 |
| JWR | Atp Release (Luminescence) | 864.7040 | 1 | 0 |
| KHF | Adenine Nucleotide Quantitation | 864.7040 | 1 | 0 |
| DDQ | Antigen, Antiserum, Control, Antithrombin Iii | 864.7060 | 2 | 4 |
| JBQ | Antithrombin Iii Quantitation | 864.7060 | 2 | 56 |
| JPE | Antithrombin Iii, Two Stage Clotting Time Assay | 864.7060 | 2 | 1 |
| JBE | Cell Enzymes (Erythrocytic And Leukocytic) | 864.7100 | 2 | 1 |
| LKZ | Red-Cell Count By Photometry | 864.7100 | 2 | 2 |
| JBP | Activated Whole Blood Clotting Time | 864.7140 | 2 | 24 |
| GGT | Assay, Erythropoietin | 864.7250 | 2 | 20 |
| JBO | Test, Euglobulin Lysis | 864.7275 | 2 | 1 |
| NPQ | Test, Factor V Leiden Mutations, Genomic Dna Pcr | 864.7280 | 2 | 6 |
| NPR | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | 864.7280 | 2 | 5 |
| OMM | Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr | 864.7280 | 2 | 2 |
| PHJ | System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations | 864.7280 | 2 | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 864.7290 | 2 | 190 |
| GJT | Plasma, Coagulation Factor Deficient | 864.7290 | 2 | 79 |
| QTY | Von Willebrand Factor Assay | 864.7293 | 2 | 1 |
| QLU | Anti-Factor Xa Activity Test System, Apixaban | 864.7295 | 2 | 3 |
| SAC | Adamts13 Activity Test System | 864.7297 | 2 | 1 |
| SES | Non-Factor Replacement Product Test System | 864.7298 | 2 | 1 |
| JBN | Fibrin Monomer Paracoagulation | 864.7300 | 2 | 2 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 864.7320 | 2 | 57 |
| GHH | Fibrin Split Products | 864.7320 | 2 | 28 |
| MIF | Prothrombin Fragment 1.2 | 864.7320 | 2 | 6 |
| DAR | Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control | 864.7340 | 2 | 0 |
| DAT | Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control | 864.7340 | 2 | 2 |
| DAX | Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control | 864.7340 | 2 | 0 |
| DAZ | Fibrinogen And Split Products, Antigen, Antiserum, Control | 864.7340 | 2 | 0 |
| GFK | Fibrinogen Determination Standards And Controls | 864.7340 | 2 | 1 |
| GFX | Fibrinogen Standard | 864.7340 | 2 | 3 |
| GIL | Plasma, Fibrinogen Control | 864.7340 | 2 | 8 |
| GIS | Test, Fibrinogen | 864.7340 | 2 | 13 |
| KQJ | System, Fibrinogen Determination | 864.7340 | 2 | 28 |
| JBF | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | 864.7360 | 2 | 5 |
| JBG | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot | 864.7360 | 2 | 0 |
| JBH | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Micromethod | 864.7360 | 2 | 0 |
| JBI | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Catalase Inhibition | 864.7360 | 2 | 0 |
| JBJ | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Methemoglobin Reduction | 864.7360 | 2 | 0 |
| JBK | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), U.V. Kinetic | 864.7360 | 2 | 0 |
| JBL | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative | 864.7360 | 2 | 2 |
| JBM | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Electrophoresis | 864.7360 | 2 | 0 |
| JLM | Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase | 864.7360 | 2 | 1 |
| JMB | Visual, Semi-Quant. (Colorimetric), Glucose-6-Phosphate Dehydrogenase | 864.7360 | 2 | 1 |
| JMC | Nadp Reduction (U.V.), Glucose-6-Phosphate Dehydrogenase | 864.7360 | 2 | 0 |
| KQE | Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase | 864.7360 | 2 | 1 |
| GII | Glutathione, Red-Cell | 864.7375 | 2 | 0 |
| JMH | Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase | 864.7375 | 2 | 0 |
| KQF | Assay, Glutathione Reductase | 864.7375 | 2 | 0 |
| JPD | Hemoglobin A2 Quantitation | 864.7400 | 2 | 13 |
| GIQ | Hemoglobin S | 864.7415 | 2 | 3 |
| GKA | Abnormal Hemoglobin Quantitation | 864.7415 | 2 | 23 |
| JCM | Control, Hemoglobin, Abnormal | 864.7415 | 2 | 12 |
| JPB | Hemoglobin M | 864.7415 | 2 | 0 |
| MLL | Hemoglobin C (Abnormal Hemoglobin Variant) | 864.7415 | 2 | 1 |
| GHS | Assay, Carboxyhemoglobin | 864.7425 | 2 | 5 |
| JBD | System, Analysis, Electrophoretic Hemoglobin | 864.7440 | 2 | 26 |
| GHA | Hemoglobin, Alkali Resistant | 864.7455 | 2 | 0 |
| GHQ | Stain, Fetal Hemoglobin | 864.7455 | 2 | 2 |
| JPC | Hemoglobin F Quantitation | 864.7455 | 2 | 1 |
| KQI | Assay, Fetal Hemoglobin | 864.7455 | 2 | 4 |
| LIM | Test, Screening, For D Positive Fetal Rbc'S | 864.7455 | 2 | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 864.7470 | 2 | 249 |
| NGB | Test, Glycosylated Hemoglobin, Over The Counter | 864.7470 | 2 | 0 |
| NOZ | Assay, 1,5-Anhydroglucitol (15ag) | 864.7470 | 2 | 2 |
| GJC | Assay, Sulfhemoglobin | 864.7490 | 2 | 0 |
| GGF | Acid Hematin | 864.7500 | 2 | 0 |
| GGZ | Oxyhemoglobin | 864.7500 | 2 | 2 |
| GIG | Hemoglobinometer | 864.7500 | 2 | 3 |
| GJZ | Cyanomethemoglobin Reagent And Standard Solution | 864.7500 | 2 | 2 |
| GKK | Cyanomethemoglobin | 864.7500 | 2 | 7 |
| GLY | Oximeter To Measure Hemoglobin | 864.7500 | 2 | 5 |
| KHG | Whole Blood Hemoglobin Determination | 864.7500 | 2 | 39 |
| LGL | Assay, Bart'S, Hemoglobin | 864.7500 | 2 | 2 |
| QGU | Hemoglobin For Donor Testing | 864.7500 | 2 | 0 |
| GFT | Protamine Sulphate | 864.7525 | 2 | 2 |
| JBR | Test, Heparin Neutralization | 864.7525 | 2 | 3 |
| KFF | Assay, Heparin | 864.7525 | 2 | 46 |
| GHD | Test, Leukocyte Alkaline Phosphatase | 864.7660 | 1 | 4 |
| JCJ | Alkaline Phosphatase | 864.7660 | 1 | 0 |
| GIA | Test, Leukocyte Peroxidase | 864.7675 | 1 | 3 |
| LGO | Test, Leukocyte Typing | 864.7675 | 1 | 5 |
| LJX | Test, Urine Leukocyte | 864.7675 | 1 | 7 |
| LCO | Platelet Factor 4 Radioimmunoassay | 864.7695 | 2 | 13 |
| GGQ | Test, Prothrombin Consumption | 864.7720 | 2 | 2 |
| JPF | Prothrombin-Proconvertin And Thrombotest | 864.7735 | 2 | 0 |
| GJS | Test, Time, Prothrombin | 864.7750 | 2 | 127 |
| ODV | Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System | 864.7750 | 2 | 1 |
| GHM | Test, Sickle Cell | 864.7825 | 2 | 18 |
| JBB | Solubility, Hemoglobin, Abnormal | 864.7825 | 2 | 2 |
| GJA | Test, Thrombin Time | 864.7875 | 2 | 20 |
| GJB | Thrombin | 864.7875 | 2 | 1 |
| GKQ | Test, Thromboplastin Generation | 864.7900 | 1 | 1 |
| GFO | Activated Partial Thromboplastin | 864.7925 | 2 | 52 |
| GGO | Reagent, Thromboplastin And Control | 864.7925 | 2 | 1 |
| GGW | Test, Time, Partial Thromboplastin | 864.7925 | 2 | 32 |
| GIT | Reagent & Control, Partial Thromboplastin Time | 864.7925 | 2 | 4 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K260551 | HemosIL Factor V Leiden (APC Resistance V) | Instrumentation Laboratory (IL) Co. | Mar 20, 2026 |
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | Jan 9, 2026 |
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | Oct 24, 2025 |
| K251440 | CRYOcheck Chromogenic Factor VIII | Precision Biologic, Inc. | Aug 25, 2025 |
| K251968 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL | Instrumentation Laboratory (IL) Co. | Jul 24, 2025 |
| K251564 | microINR System | Iline Microsystems, S.L. | Jul 21, 2025 |
| DEN240035 | ConcizuTrace ELISA | Randox Laboratories, Ltd. | May 22, 2025 |
| K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH | Mar 28, 2025 |
| K243543 | microINR System | Iline Microsystems, S.L. | Feb 27, 2025 |
| K250218 | Xpert® FII & FV | Cepheid | Feb 21, 2025 |
| K243374 | HemosIL CL HIT-IgG(PF4-H) | Instrumentation Laboratory (IL) Co. | Jan 28, 2025 |
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Nov 22, 2024 |
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | Siemens Healthcare Diagnostics Products GmbH | Oct 10, 2024 |
| K240182 | Access EPO | Beckman Coulter, Inc. | Apr 22, 2024 |
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia | Apr 4, 2024 |
| K230802 | Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. | Mar 15, 2024 |
| DEN230024 | Technozym ADAMTS13 Activity | Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM | Feb 28, 2024 |
| K230852 | HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company | Dec 13, 2023 |
| K231465 | Q-Pad Test System | Qurasense | Dec 6, 2023 |
| K221508 | AnemoCheck Home | Sanguina, Inc. | Sep 29, 2023 |
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | Abbott Diagnostics Technologies AS | Sep 27, 2023 |
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | Sep 13, 2023 |
| K222635 | Premier Resolution System | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | Aug 4, 2023 |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Abbott Laboratories | Jul 14, 2023 |
| K231711 | microINR System | Iline Microsystems, S.L. | Jul 11, 2023 |
| K223187 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | Jun 23, 2023 |
| K231045 | Healgen URS Test Strips | Healgen Scientific,, LLC | Jun 16, 2023 |
| K220728 | vWF Ag | Siemens Healthcare Diagnostics Products GmbH | Jun 2, 2023 |
| K223046 | Xpert® FII & FV | Cepheid® | Feb 15, 2023 |
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | Sienco, Inc. | Jan 4, 2023 |
| K214002 | CRYOcheck Chromogenic Factor IX | Precision Biologic, Inc. | Dec 23, 2022 |
| K211485 | STA- NeoPTimal | Diagnostica Stago S.A.S | Dec 23, 2022 |
| K223402 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | Dec 9, 2022 |
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | Coagusense, Inc. | Oct 5, 2022 |
| K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | Oct 4, 2022 |
| DEN200067 | INNOVANCE VWF Ac | Siemens Healthcare Diagnostics Products GmbH | Sep 29, 2022 |
| K201049 | FINDER G6PD | Baebies, Inc. | Sep 14, 2022 |
| K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory CO | Aug 16, 2022 |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | Helena Laboratories, Corp. | Apr 19, 2022 |
| K201185 | microINR System | Iline Microsystems, S.L. | Dec 18, 2020 |
| K193556 | Cryocheck Hex LA | Precision Biologic | Oct 23, 2020 |
| DEN190032 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | Sep 17, 2020 |
| K201570 | PF4 Enhanced assay | Immucor Gti Diagnostics, Inc. | Sep 11, 2020 |
| K200033 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory CO | Aug 19, 2020 |
| K193204 | Cryocheck Chromogenic Factor VIII | Precision Biologic | Jul 17, 2020 |
| K201311 | PF4 IgG assay | Immucor Gti Diagnostics, Inc. | Jun 18, 2020 |
| K200204 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Apr 6, 2020 |
| K192987 | Aina HbA1c Monitoring System 2 | Jana Care, Inc. | Mar 26, 2020 |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | Oct 29, 2019 |
| K183230 | OneDraw A1C Test System | Drawbridge Health, Inc. | Aug 15, 2019 |
| K183088 | ADVIA Centaur Erythropoietin (EPO) assay | Axis-Shield Diagnostics Limited | Aug 2, 2019 |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | Apr 12, 2019 |
| K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer | Beckman Coulter | Mar 21, 2019 |
| K183440 | CRYOcheck FVIII Inhibitor Kit | Precision Biologic, Inc. | Mar 12, 2019 |
| K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | Feb 21, 2019 |
| K180509 | Quo-Test A1c System | Ekf-Diagnostic GmbH | Feb 16, 2019 |
| K180780 | microINR System | Iline Microsystems, S.L. | Jan 25, 2019 |
| K180762 | CAPI 3 HEMOGLOBIN(E) | Sebia | Dec 14, 2018 |
| K180209 | Diazyme 1,5-AG Assay | Diazyme Laboratories, Inc. | Oct 4, 2018 |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) | Skyla Corporation H.S.P.B | Sep 25, 2018 |
| K181525 | INNOVANCE Free PS Ag | Siemens Healthcare Diagnostics Products GmbH | Sep 7, 2018 |
| K180186 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Aug 23, 2018 |
| K180693 | CoaguChek XS Pro System | Roche Diagnostics | Apr 19, 2018 |
| K180684 | CoaguChek XS Plus System | Roche Diagnostics | Apr 19, 2018 |
| K180486 | HemosIL Factor XII Deficient Plasma | Instrumentation Laboratory CO | Mar 22, 2018 |
| K170623 | ACE Hemoglobin A1c (HbA1c) Reagent | Alfa Wassermann Diagnostic Technologies, LLC | Feb 27, 2018 |
| K172913 | cobas Factor II and Factor V Test | Roche Molecular Systems, Inc. | Jan 12, 2018 |
| K170960 | CoaguChek Vantus System | Roche Diagnostics | Dec 25, 2017 |
| K172903 | HemosIL D-Dimer HS 500 | Instrumentation Laboratory CO | Nov 22, 2017 |
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | Nov 21, 2017 |
| K170147 | Lucica Glycated Albumin-L | Asahi Kasei Pharma Corporation | Oct 12, 2017 |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | Bio-Rad Laboratories, Inc. | Sep 13, 2017 |
| K163215 | AnemoCheck | Sanguina, LLC | Sep 13, 2017 |
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | Sep 8, 2017 |
| K162540 | INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls | Siemens Healthcare Diagnostics Prodcts GmbH | Aug 22, 2017 |
| K163633 | cobas HbA1c Test, cobas b 101 system | Roche Diagnostics Operations | Jul 28, 2017 |
| DEN160047 | ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M | Beckman Coulter | Jun 29, 2017 |
| K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | Jun 16, 2017 |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | Sebia | Feb 17, 2017 |
| K162227 | STA® - Liatest® D-Di | Diagnostica Stago | Dec 10, 2016 |
| K160762 | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set | Diazyme Laboratories | Nov 21, 2016 |
| K160885 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | Oct 27, 2016 |
| K151964 | Xprecia Stride Coagulation System, Xprecia System PT Controls | Siemens Healthcare Diagnostics | Sep 30, 2016 |
| K153137 | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | Instrumentation Laboratory CO | Jul 8, 2016 |
| K161364 | BinaxNOW G6PD Test | Alere Scarborough, Inc. | Jun 17, 2016 |
| K160445 | HemosIL Silica Clotting Time | Instrumentation Laboratory CO | Mar 16, 2016 |
| K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set | Diazyme Laboratories | Jan 31, 2016 |
| K142664 | URight Hemoglobin A1c system, FORA A1c System | Taidoc Technology Corporation | Jan 29, 2016 |
| K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | Sd Biosensor, Inc. | Sep 30, 2015 |
| K151809 | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | Alere Technologies AS | Sep 25, 2015 |
| K151534 | HemosIL D-Dimer HS | Instrumentation Laboratory CO | Jul 6, 2015 |
| K141944 | HOME ACCESS AIC TEST | Home Access Health Corp. | Mar 13, 2015 |
| K142789 | A1c iGear System | Sakae Corporation | Dec 16, 2014 |
| K141144 | STA LIATEST D-DI | Diagnostica Stago | Sep 3, 2014 |
| K133803 | DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT | Diazyme Laboratories | Aug 6, 2014 |
| K141750 | HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM | Infopia Co, Ltd. | Jul 24, 2014 |
| K140829 | UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT | Beckman Coulter, Inc. | Jul 14, 2014 |
| K140801 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM | Bio-Rad Laboratories, Inc. | Jun 25, 2014 |
| K132978 | IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TEST | Sequenom, Inc. | Jun 13, 2014 |
| K130014 | A1C GEAR SYSTEM | Sakae Corporation | Apr 4, 2014 |
