GJS · Test, Time, Prothrombin
Hematology · 21 CFR 864.7750 · Class 2
Overview
| Product Code | GJS |
|---|---|
| Device Name | Test, Time, Prothrombin |
| Regulation | 21 CFR 864.7750 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).
Classification Rationale
Class II (performance standards).
Cleared Devices (127)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | Oct 24, 2025 | SESE |
| K251564 | microINR System | Iline Microsystems, S.L. | Jul 21, 2025 | SESE |
| K243543 | microINR System | Iline Microsystems, S.L. | Feb 27, 2025 | SESE |
| K230802 | Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. | Mar 15, 2024 | SESE |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Abbott Laboratories | Jul 14, 2023 | SESE |
| K231711 | microINR System | Iline Microsystems, S.L. | Jul 11, 2023 | SESE |
| K211485 | STA- NeoPTimal | Diagnostica Stago S.A.S | Dec 23, 2022 | SESE |
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | Coagusense, Inc. | Oct 5, 2022 | SESE |
| K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory CO | Aug 16, 2022 | SESE |
| K201185 | microINR System | Iline Microsystems, S.L. | Dec 18, 2020 | SESE |
| K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | Feb 21, 2019 | SESE |
| K180780 | microINR System | Iline Microsystems, S.L. | Jan 25, 2019 | SESE |
| K180693 | CoaguChek XS Pro System | Roche Diagnostics | Apr 19, 2018 | SESE |
| K180684 | CoaguChek XS Plus System | Roche Diagnostics | Apr 19, 2018 | SESE |
| K170960 | CoaguChek Vantus System | Roche Diagnostics | Dec 25, 2017 | SESE |
| K151964 | Xprecia Stride Coagulation System, Xprecia System PT Controls | Siemens Healthcare Diagnostics | Sep 30, 2016 | SESE |
| K132722 | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) | Instrumentation Laboratory CO | Jan 22, 2014 | SESE |
| K122584 | HEMOSIL READIPLAS TIN | Instrumentation Laboratory CO | Mar 24, 2013 | SESE |
| K110212 | INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP | Alere San Diego, Inc (Formally Biosite Incorporate | May 1, 2012 | SESU |
| K092987 | INRATIO/INRATIO2 TEST STRIPS | Biosite Incorporated | Jun 11, 2010 | SESE |
| K093243 | COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM | Coagusense, Inc. | Apr 7, 2010 | SESE |
| K093460 | COAGUCHEK XS PRO SYSTEM | Roche Diagnostics | Mar 18, 2010 | SESE |
| K092940 | COAGUCHEK XS PLUS PST SYSTEM | Roche Diagnostics Corp. | Mar 5, 2010 | SESE |
| K072920 | HANDHELD BASE UNIT | Roche Diagnostics Corp. | Jan 31, 2008 | SESE |
| K072727 | INRATIO 2 PT MONITORING SYSTEM | Hemosense, Inc. | Oct 26, 2007 | SESE |
| K070005 | HEMOSIL RECOMBIPLASTIN 2G | Instrumentation Laboratory CO | Aug 15, 2007 | SESE |
| K071041 | COAGUCHEK XS PLUS SYSTEM | Roche Diagnostics | May 11, 2007 | SESE |
| K062925 | COAGUCHEK XS SYSTEM | Roche Diagnostics Corp. | Jan 29, 2007 | SESE |
| K060978 | COAGUCHEK XS SYSTEM | Roche Diagnostics | Aug 11, 2006 | SESE |
| K060931 | HEMOSIL PT-FIBRINOGEN HS PLUS | Instrumentation Laboratory CO | May 2, 2006 | SESE |
| K052124 | ACTICLOT, MODEL 824 | American Diagnostica, Inc. | Oct 17, 2005 | SESE |
| K043184 | HEMOSIL RECOMBIPLASTIN | Instrumentation Laboratory CO | Dec 22, 2004 | SESE |
| K040296 | PHOSPHOPLASTIN RL | R2 Diagnostics, Inc. | May 24, 2004 | SESE |
| K030845 | COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING | Roche Diagnostics Corp. | May 22, 2003 | SESE |
| K021190 | PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 | Roche Diagnostics Corp. | Oct 25, 2002 | SESE |
| K021923 | INRATIO SELF-TEST | Hemosense, Inc. | Oct 24, 2002 | SESE |
| K020831 | PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 | Roche Diagnostics Corp. | Oct 24, 2002 | SESE |
| K022922 | HARMONY INR MONITORING SYSTEM | Lifescan, Inc. | Sep 30, 2002 | SESE |
| K020840 | VITAL SCIENTIFIC PT WITH CALCIUM | Vital Scientific N.V. | May 15, 2002 | SESE |
| K020355 | I-STAT PROTHROMBIN TIME TEST | I-Stat Corporation | May 14, 2002 | SESE |
| K020679 | INRATIO | Hemosense, Inc. | May 6, 2002 | SESE |
| K013155 | DADE THROMBOPLASTIN C PLUS | Dade Behring, Inc. | Jan 18, 2002 | SESE |
| K012768 | HEMOSIL RECOMBI PLASTIN | Instrumentation Laboratory CO | Sep 18, 2001 | SESE |
| K010599 | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE | International Technidyne Corp. | Jul 2, 2001 | SESE |
| K001699 | RUBICON PROTHROMBIN TIME MONITORING SYSTEM | Lifescan, Inc. | May 15, 2001 | SESE |
| K003870 | THROMBOREL S | Dade Behring, Inc. | Feb 20, 2001 | SESE |
| K994100 | PACIFIC HEMOSTASIS THROMBOPLASTIN D | Pacific Hemostasis | Feb 18, 2000 | SESE |
| K994006 | AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) | Avocet Medical, Inc. | Feb 3, 2000 | SESE |
| K991286 | AVOCET ACUSURE SYSTEM | Avocet Medical, Inc. | Nov 18, 1999 | SESE |
| K992492 | PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM | Roche Diagnostics Corp. | Nov 2, 1999 | SESE |
| K991065 | CARESIDE PT | Careside, Inc. | Jul 26, 1999 | SESE |
| K972866 | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT | International Technidyne Corp. | Sep 30, 1998 | SESE |
| K974343 | DADE INNOVIN | Dade Intl., Inc. | Jul 22, 1998 | SESE |
| K981479 | IL TEST PT-FIBRINOGEN RECOMBINANT | Instrumentation Laboratory CO | Jul 7, 1998 | SESE |
| K974566 | MDA SIMPLASTIN HTF | Organon Teknika Corp. | Feb 24, 1998 | SESE |
| K972796 | SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM | Sigma Diagnostics, Inc. | Oct 10, 1997 | SESE |
| K962571 | COAGUCHEK PST SYSTEM | Boehringer Mannheim Corp. | Apr 22, 1997 | SESE |
| K961835 | PROTIME MICROCOAGULATION SYSTEM | International Technidyne Corp. | Mar 12, 1997 | SESE |
| K961938 | STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS | Nova Biomedical Corp. | Jun 28, 1996 | SESE |
| K955843 | TAS PTONE | Cardiovascular Diagnostic Services | Mar 18, 1996 | SESE |
| K954625 | PROTHROMBIN TIME TEST CARD | Cardiovascular Diagnostics, Inc. | Mar 11, 1996 | SESE |
| K951820 | THROMBOPLASTIN-LI REAGENT | Helena Laboratories | Oct 20, 1995 | SESE |
| K952608 | MDA SIMPLASTIN LS | Organon Teknika Corp. | Oct 6, 1995 | SESE |
| K942884 | COAGUCHEK SYSTEM | Boehringer Mannheim Corp. | May 11, 1995 | SESE |
| K945078 | HEMOCHRON HNPT/FACTOR VI PT+ | International Technidyne Corp. | Apr 28, 1995 | SESE |
| K935748 | ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT | Ortho Diagnostic Systems, Inc. | Apr 26, 1995 | SESE |
| K940082 | THROMBOSCREEN THROMBOPLASTIN-DS | Pacific Hemostasis | Feb 14, 1995 | SESE |
| K935702 | DADE INNOVIN II | Baxter Diagnostics, Inc. | Nov 22, 1994 | SESE |
| K940432 | MICROCOAGULATION PROTHROMBIN TIME TEST | International Technidyne Corp. | May 18, 1994 | SESE |
| K940310 | HELENA THROMBOPLASTIN-MI REAGENT | Helena Laboratories | Apr 20, 1994 | SESE |
| K931118 | ASSESS(TM) HIGH ABNORMAL CONTROL | Instrumentation Laboratory CO | Mar 30, 1994 | SESE |
| K931117 | ASSESS(TM) LOW ABNORMAL CONTROL | Instrumentation Laboratory CO | Mar 30, 1994 | SESE |
| K933252 | IL TEST (TM) PT-FIBRINOGEN HS PLUS | Instrumentation Laboratory CO | Oct 4, 1993 | SESE |
| K930212 | THROMBOPLATIN-M WITH CALCIUM | Sigma Diagnostics, Inc. | May 11, 1993 | SESE |
| K925604 | ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT | Ortho Diagnostic Systems, Inc. | Mar 12, 1993 | SESE |
| K920767 | NYCOPLASTIN | Nycomed Pharma AS | Feb 12, 1993 | SESE |
| K925492 | BIOMERIEUX HEMOLAB THROMBOMAT | Biomerieux Vitek, Inc. | Feb 3, 1993 | SESE |
| K922565 | NEOPLASTINE(R) CI KIT | American Bioproducts Co. | Dec 7, 1992 | SESE |
| K921326 | DADE RECOMBOPLASTIN S | Baxter Diagnostics, Inc. | Jul 27, 1992 | SESE |
| K922040 | NEOPLASTINE CI PLUS | American Bioproducts Co. | Jun 23, 1992 | SESE |
| K915746 | SIMPLASTIN L | Organon Teknika Corp. | Feb 12, 1992 | SESE |
| K913249 | ACS ULTRA-1 THROMBOPLASTIN | Analytical Control Systems, Inc. | Dec 4, 1991 | SESE |
| K913250 | ACS ULTRA-2 THROMBOPLASTIN | Analytical Control Systems, Inc. | Nov 27, 1991 | SESE |
| K912102 | ACS LIQUID THROMBOPLASTIN | Analytical Control Systems, Inc. | Aug 9, 1991 | SESE |
| K911995 | PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION | International Technidyne Corp. | Jul 17, 1991 | SESE |
| K905807 | HELENA THROMBOPLASTIN REAGENT WITH DILUENT | Helena Laboratories | Apr 16, 1991 | SESE |
| K905857 | HELENA THROMBOPLASTIN REAGENT, MODIFICATION | Helena Laboratories | Feb 27, 1991 | SESE |
| K904325 | COAG-1 PT-NC TEST CARD | Cardiovascular Diagnostic Services | Jan 25, 1991 | SESE |
| K904454 | HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION | International Technidyne Corp. | Dec 17, 1990 | SESE |
| K902468 | ACS ONE-STAGE PROTHROMBIN TIME REAGENT | Analytical Control Systems, Inc. | Aug 10, 1990 | SESE |
| K903019 | MODIFIED COAG-1 PT TEST CARD | Cardiovascular Diagnostic Services | Aug 1, 1990 | SESE |
| K902096 | THROMBOPLASTIN WITH CALCIUM | Sigma Chemical Co. | Jul 3, 1990 | SESE |
| K901325 | THROMBOPLASTIN.C PLUS | Baxter Healthcare Corp | May 2, 1990 | SESE |
| K896625 | THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. | Medical Diagnostic Technologies, Inc. | Dec 11, 1989 | SESE |
| K885107 | THROMBOSTIN IFA* | Investigacion Farmaceutica S.A. DE C.V. | Jun 23, 1989 | SESE |
| K893378 | PROTHROMBIN TIME (PT) BY HEMOCHRON | International Technidyne Corp. | Jun 22, 1989 | SESE |
| K892050 | HELENA THROMBOPLASTIN REAGENT | Helena Laboratories | Jun 7, 1989 | SESE |
| K891370 | EDL ONE-STAGE PROTHROMBIN TIME REAGENT | Elite Diagnostic , Ltd. | Apr 21, 1989 | SESE |
| K891169 | DADE THROMBOPLASTIN IS | Baxter Healthcare Corp | Apr 10, 1989 | SESE |
| K884855 | THROMBOPLASTIN | Precision Biologicals, Inc. | Jan 30, 1989 | SESE |
| K883441 | VISION(R) PROTHROMBIN TIME | Abbott Laboratories | Sep 13, 1988 | SESE |
| K882456 | COAG-I PT TEST CARD | Cardiovascular Diagnostic Services | Aug 25, 1988 | SESE |
| K882214 | SIMPLASTIN EXCEL S | Organon Teknika Corp. | Jul 1, 1988 | SESE |
| K880566 | CLP PROTHROMBIN TIME TEST | Creative Laboratory Products, Inc. | Mar 23, 1988 | SESE |
| K875062 | EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 | Em Diagnostic Systems, Inc. | Feb 11, 1988 | SESE |
| K874592 | THROMBOPLASTIN.C | Baxter Healthcare Corp | Feb 4, 1988 | SESE |
| K872537 | PROTHROMBIN TIME TEST | Sclavo, Inc. | Aug 27, 1987 | SESE |
| K872844 | THROMBOREL S | Behring Diagnostics, Inc. | Aug 6, 1987 | SESE |
| K870596 | PROTHROMBIN TIME TEST | U. S. Diagnostics, Inc. | Apr 20, 1987 | SESE |
| K864392 | PROTIME AUTOMATE TEST KIT | American Bioproducts Co. | Jan 5, 1987 | SESE |
| K864283 | SIMPLASTIN EXCEL | Organon Teknika Corp. | Dec 4, 1986 | SESE |
| K864274 | THROMBOPLASTIN.R | American Dade | Nov 13, 1986 | SESE |
| K864273 | THROMBOPLASTIN.C | American Dade | Nov 13, 1986 | SESE |
| K864272 | THROMBOPLASTIN.FS | American Dade | Nov 13, 1986 | SESE |
| K860721 | BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST | Biotrack, Inc. | May 23, 1986 | SESE |
| K852484 | PLASTINEX | Bio/Data Corp. | Aug 12, 1985 | SESE |
| K851125 | ACA PROTHROMBIN TIME ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | May 29, 1985 | SESE |
| K843535 | ORTHO BRAIN THROMBOPLASTIN DILUENT | Ortho Diagnostic Systems, Inc. | Dec 12, 1984 | SESE |
| K840802 | DIA THROMBIN DIA PLASTIN | Diatech, Inc. | May 1, 1984 | SESE |
| K832427 | EASYTOUCH TROMBOPLASTIN REAGENT | Worthington Diagnostic Systems | Oct 14, 1983 | SESE |
| K830331 | LIQUID THROMBOPLASTIN REAGENT | Helena Laboratories | Apr 5, 1983 | SESE |
| K811784 | SIGMA PROCEDURE #890 | Sigma Chemical Co. | Jul 27, 1981 | SESE |
| K810350 | THROMBOPLASTIN | Pacific Hemostasis | Apr 14, 1981 | SESE |
| K792031 | LANCER COAGENT PT KIT | Sherwood Medical Co. | Nov 5, 1979 | SESE |
| K791022 | PROTHROMBIN REFERENCE PLASMA (HUMAN) | Pacific Hemostasis | Jul 24, 1979 | SESE |
| K791023 | PROTHROMBIN FREE BEEF PLASMA (PFB) | Pacific Hemostasis | Jun 28, 1979 | SESE |
| K780203 | THROMBOPLASTIN DRIED | Hyland Therapeutic Div., Travenol Laboratories | Mar 27, 1978 | SESE |
Top Applicants
- Instrumentation Laboratory CO — 11 clearances
- International Technidyne Corp. — 8 clearances
- Roche Diagnostics Corp. — 7 clearances
- Roche Diagnostics — 7 clearances
- Helena Laboratories — 6 clearances
