Product Code: GJS FDA class 2 21 CFR 864.7750

Test, Time, Prothrombin

Hematology

The Test, Time, Prothrombin (product code GJS) is a hematology coagulation assay system used to perform the prothrombin time (PT) test, which evaluates the extrinsic and common coagulation pathways, monitors warfarin anticoagulation therapy, and screens for clotting factor deficiencies. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7750 in the Hematology specialty (HE), this device carries no flags for third-party review, implantation, life support, or GMP exemption.

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510(k)s

127

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GJS
Device Class: FDA class 2
Regulation Number: 864.7750
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 127 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253188	CoaguChek XS Plus System	Oct 24, 2025	Substantially Equivalent	Roche Diagnostics
K251564	microINR System	Jul 21, 2025	Substantially Equivalent	Iline Microsystems, S.L.
K243543	microINR System	Feb 27, 2025	Substantially Equivalent	Iline Microsystems, S.L.
K230802	Xprecia Prime Coagulation System	Mar 15, 2024	Substantially Equivalent	Universal Biosensors Pty, Ltd.
K220282	i-STAT PTplus Cartridge with the i-STAT 1 System	Jul 14, 2023	Substantially Equivalent	Abbott Laboratories
K231711	microINR System	Jul 11, 2023	Substantially Equivalent	Iline Microsystems, S.L.
K211485	STA- NeoPTimal	Dec 23, 2022	Substantially Equivalent	Diagnostica Stago S.A.S
K212779	Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing	Oct 05, 2022	Substantially Equivalent	Coagusense, Inc.
K213426	HemosIL ReadiPlasTin	Aug 16, 2022	Substantially Equivalent	Instrumentation Laboratory CO
K201185	microINR System	Dec 18, 2020	Substantially Equivalent	Iline Microsystems, S.L.
K183255	Coag-Sense Prothrombin Time (PT) / INR Monitoring Device	Feb 21, 2019	Substantially Equivalent	Coagusense, Inc.
K180780	microINR System	Jan 25, 2019	Substantially Equivalent	Iline Microsystems, S.L.
K180693	CoaguChek XS Pro System	Apr 19, 2018	Substantially Equivalent	Roche Diagnostics
K180684	CoaguChek XS Plus System	Apr 19, 2018	Substantially Equivalent	Roche Diagnostics
K170960	CoaguChek Vantus System	Dec 25, 2017	Substantially Equivalent	Roche Diagnostics
K151964	Xprecia Stride Coagulation System, Xprecia System PT Controls	Sep 30, 2016	Substantially Equivalent	Siemens Healthcare Diagnostics
K132722	HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)	Jan 22, 2014	Substantially Equivalent	Instrumentation Laboratory CO
K122584	HEMOSIL READIPLAS TIN	Mar 24, 2013	Substantially Equivalent	Instrumentation Laboratory CO
K110212	INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP	May 01, 2012	Unknown	Alere San Diego, Inc (Formally Biosite Incorporate
K092987	INRATIO/INRATIO2 TEST STRIPS	Jun 11, 2010	Substantially Equivalent	Biosite Incorporated
K093243	COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM	Apr 07, 2010	Substantially Equivalent	Coagusense, Inc.
K093460	COAGUCHEK XS PRO SYSTEM	Mar 18, 2010	Substantially Equivalent	Roche Diagnostics
K092940	COAGUCHEK XS PLUS PST SYSTEM	Mar 05, 2010	Substantially Equivalent	Roche Diagnostics Corp.
K072920	HANDHELD BASE UNIT	Jan 31, 2008	Substantially Equivalent	Roche Diagnostics Corp.
K072727	INRATIO 2 PT MONITORING SYSTEM	Oct 26, 2007	Substantially Equivalent	Hemosense, Inc.
K070005	HEMOSIL RECOMBIPLASTIN 2G	Aug 15, 2007	Substantially Equivalent	Instrumentation Laboratory CO
K071041	COAGUCHEK XS PLUS SYSTEM	May 11, 2007	Substantially Equivalent	Roche Diagnostics
K062925	COAGUCHEK XS SYSTEM	Jan 29, 2007	Substantially Equivalent	Roche Diagnostics Corp.
K060978	COAGUCHEK XS SYSTEM	Aug 11, 2006	Substantially Equivalent	Roche Diagnostics
K060931	HEMOSIL PT-FIBRINOGEN HS PLUS	May 02, 2006	Substantially Equivalent	Instrumentation Laboratory CO
K052124	ACTICLOT, MODEL 824	Oct 17, 2005	Substantially Equivalent	American Diagnostica, Inc.
K043184	HEMOSIL RECOMBIPLASTIN	Dec 22, 2004	Substantially Equivalent	Instrumentation Laboratory CO
K040296	PHOSPHOPLASTIN RL	May 24, 2004	Substantially Equivalent	R2 Diagnostics, Inc.
K030845	COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING	May 22, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K021190	PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422	Oct 25, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K021923	INRATIO SELF-TEST	Oct 24, 2002	Substantially Equivalent	Hemosense, Inc.
K020831	PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404	Oct 24, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K022922	HARMONY INR MONITORING SYSTEM	Sep 30, 2002	Substantially Equivalent	Lifescan, Inc.
K020840	VITAL SCIENTIFIC PT WITH CALCIUM	May 15, 2002	Substantially Equivalent	Vital Scientific N.V.
K020355	I-STAT PROTHROMBIN TIME TEST	May 14, 2002	Substantially Equivalent	I-Stat Corporation
K020679	INRATIO	May 06, 2002	Substantially Equivalent	Hemosense, Inc.
K013155	DADE THROMBOPLASTIN C PLUS	Jan 18, 2002	Substantially Equivalent	Dade Behring, Inc.
K012768	HEMOSIL RECOMBI PLASTIN	Sep 18, 2001	Substantially Equivalent	Instrumentation Laboratory CO
K010599	PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE	Jul 02, 2001	Substantially Equivalent	International Technidyne Corp.
K001699	RUBICON PROTHROMBIN TIME MONITORING SYSTEM	May 15, 2001	Substantially Equivalent	Lifescan, Inc.
K003870	THROMBOREL S	Feb 20, 2001	Substantially Equivalent	Dade Behring, Inc.
K994100	PACIFIC HEMOSTASIS THROMBOPLASTIN D	Feb 18, 2000	Substantially Equivalent	Pacific Hemostasis
K994006	AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)	Feb 03, 2000	Substantially Equivalent	Avocet Medical, Inc.
K991286	AVOCET ACUSURE SYSTEM	Nov 18, 1999	Substantially Equivalent	Avocet Medical, Inc.
K992492	PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM	Nov 02, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K991065	CARESIDE PT	Jul 26, 1999	Substantially Equivalent	Careside, Inc.
K972866	HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT	Sep 30, 1998	Substantially Equivalent	International Technidyne Corp.
K974343	DADE INNOVIN	Jul 22, 1998	Substantially Equivalent	Dade Intl., Inc.
K981479	IL TEST PT-FIBRINOGEN RECOMBINANT	Jul 07, 1998	Substantially Equivalent	Instrumentation Laboratory CO
K974566	MDA SIMPLASTIN HTF	Feb 24, 1998	Substantially Equivalent	Organon Teknika Corp.
K972796	SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM	Oct 10, 1997	Substantially Equivalent	Sigma Diagnostics, Inc.
K962571	COAGUCHEK PST SYSTEM	Apr 22, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K961835	PROTIME MICROCOAGULATION SYSTEM	Mar 12, 1997	Substantially Equivalent	International Technidyne Corp.
K961938	STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS	Jun 28, 1996	Substantially Equivalent	Nova Biomedical Corp.
K955843	TAS PTONE	Mar 18, 1996	Substantially Equivalent	Cardiovascular Diagnostic Services
K954625	PROTHROMBIN TIME TEST CARD	Mar 11, 1996	Substantially Equivalent	Cardiovascular Diagnostics, Inc.
K951820	THROMBOPLASTIN-LI REAGENT	Oct 20, 1995	Substantially Equivalent	Helena Laboratories
K952608	MDA SIMPLASTIN LS	Oct 06, 1995	Substantially Equivalent	Organon Teknika Corp.
K942884	COAGUCHEK SYSTEM	May 11, 1995	Substantially Equivalent	Boehringer Mannheim Corp.
K945078	HEMOCHRON HNPT/FACTOR VI PT+	Apr 28, 1995	Substantially Equivalent	International Technidyne Corp.
K935748	ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT	Apr 26, 1995	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K940082	THROMBOSCREEN THROMBOPLASTIN-DS	Feb 14, 1995	Substantially Equivalent	Pacific Hemostasis
K935702	DADE INNOVIN II	Nov 22, 1994	Substantially Equivalent	Baxter Diagnostics, Inc.
K940432	MICROCOAGULATION PROTHROMBIN TIME TEST	May 18, 1994	Substantially Equivalent	International Technidyne Corp.
K940310	HELENA THROMBOPLASTIN-MI REAGENT	Apr 20, 1994	Substantially Equivalent	Helena Laboratories
K931118	ASSESS(TM) HIGH ABNORMAL CONTROL	Mar 30, 1994	Substantially Equivalent	Instrumentation Laboratory CO
K931117	ASSESS(TM) LOW ABNORMAL CONTROL	Mar 30, 1994	Substantially Equivalent	Instrumentation Laboratory CO
K933252	IL TEST (TM) PT-FIBRINOGEN HS PLUS	Oct 04, 1993	Substantially Equivalent	Instrumentation Laboratory CO
K930212	THROMBOPLATIN-M WITH CALCIUM	May 11, 1993	Substantially Equivalent	Sigma Diagnostics, Inc.
K925604	ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT	Mar 12, 1993	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K920767	NYCOPLASTIN	Feb 12, 1993	Substantially Equivalent	Nycomed Pharma AS
K925492	BIOMERIEUX HEMOLAB THROMBOMAT	Feb 03, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K922565	NEOPLASTINE(R) CI KIT	Dec 07, 1992	Substantially Equivalent	American Bioproducts Co.
K921326	DADE RECOMBOPLASTIN S	Jul 27, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K922040	NEOPLASTINE CI PLUS	Jun 23, 1992	Substantially Equivalent	American Bioproducts Co.
K915746	SIMPLASTIN L	Feb 12, 1992	Substantially Equivalent	Organon Teknika Corp.
K913249	ACS ULTRA-1 THROMBOPLASTIN	Dec 04, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K913250	ACS ULTRA-2 THROMBOPLASTIN	Nov 27, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K912102	ACS LIQUID THROMBOPLASTIN	Aug 09, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K911995	PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION	Jul 17, 1991	Substantially Equivalent	International Technidyne Corp.
K905807	HELENA THROMBOPLASTIN REAGENT WITH DILUENT	Apr 16, 1991	Substantially Equivalent	Helena Laboratories
K905857	HELENA THROMBOPLASTIN REAGENT, MODIFICATION	Feb 27, 1991	Substantially Equivalent	Helena Laboratories
K904325	COAG-1 PT-NC TEST CARD	Jan 25, 1991	Substantially Equivalent	Cardiovascular Diagnostic Services
K904454	HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION	Dec 17, 1990	Substantially Equivalent	International Technidyne Corp.
K902468	ACS ONE-STAGE PROTHROMBIN TIME REAGENT	Aug 10, 1990	Substantially Equivalent	Analytical Control Systems, Inc.
K903019	MODIFIED COAG-1 PT TEST CARD	Aug 01, 1990	Substantially Equivalent	Cardiovascular Diagnostic Services
K902096	THROMBOPLASTIN WITH CALCIUM	Jul 03, 1990	Substantially Equivalent	Sigma Chemical Co.
K901325	THROMBOPLASTIN.C PLUS	May 02, 1990	Substantially Equivalent	Baxter Healthcare Corp
K896625	THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.	Dec 11, 1989	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K885107	THROMBOSTIN IFA*	Jun 23, 1989	Substantially Equivalent	Investigacion Farmaceutica S.A. DE C.V.
K893378	PROTHROMBIN TIME (PT) BY HEMOCHRON	Jun 22, 1989	Substantially Equivalent	International Technidyne Corp.
K892050	HELENA THROMBOPLASTIN REAGENT	Jun 07, 1989	Substantially Equivalent	Helena Laboratories
K891370	EDL ONE-STAGE PROTHROMBIN TIME REAGENT	Apr 21, 1989	Substantially Equivalent	Elite Diagnostic , Ltd.
K891169	DADE THROMBOPLASTIN IS	Apr 10, 1989	Substantially Equivalent	Baxter Healthcare Corp
K884855	THROMBOPLASTIN	Jan 30, 1989	Substantially Equivalent	Precision Biologicals, Inc.
K883441	VISION(R) PROTHROMBIN TIME	Sep 13, 1988	Substantially Equivalent	Abbott Laboratories
K882456	COAG-I PT TEST CARD	Aug 25, 1988	Substantially Equivalent	Cardiovascular Diagnostic Services
K882214	SIMPLASTIN EXCEL S	Jul 01, 1988	Substantially Equivalent	Organon Teknika Corp.
K880566	CLP PROTHROMBIN TIME TEST	Mar 23, 1988	Substantially Equivalent	Creative Laboratory Products, Inc.
K875062	EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628	Feb 11, 1988	Substantially Equivalent	Em Diagnostic Systems, Inc.
K874592	THROMBOPLASTIN.C	Feb 04, 1988	Substantially Equivalent	Baxter Healthcare Corp
K872537	PROTHROMBIN TIME TEST	Aug 27, 1987	Substantially Equivalent	Sclavo, Inc.
K872844	THROMBOREL S	Aug 06, 1987	Substantially Equivalent	Behring Diagnostics, Inc.
K870596	PROTHROMBIN TIME TEST	Apr 20, 1987	Substantially Equivalent	U. S. Diagnostics, Inc.
K864392	PROTIME AUTOMATE TEST KIT	Jan 05, 1987	Substantially Equivalent	American Bioproducts Co.
K864283	SIMPLASTIN EXCEL	Dec 04, 1986	Substantially Equivalent	Organon Teknika Corp.
K864274	THROMBOPLASTIN.R	Nov 13, 1986	Substantially Equivalent	American Dade
K864273	THROMBOPLASTIN.C	Nov 13, 1986	Substantially Equivalent	American Dade
K864272	THROMBOPLASTIN.FS	Nov 13, 1986	Substantially Equivalent	American Dade
K860721	BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST	May 23, 1986	Substantially Equivalent	Biotrack, Inc.
K852484	PLASTINEX	Aug 12, 1985	Substantially Equivalent	Bio/Data Corp.
K851125	ACA PROTHROMBIN TIME ANALYTICAL TEST PACK	May 29, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K843535	ORTHO BRAIN THROMBOPLASTIN DILUENT	Dec 12, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K840802	DIA THROMBIN DIA PLASTIN	May 01, 1984	Substantially Equivalent	Diatech, Inc.
K832427	EASYTOUCH TROMBOPLASTIN REAGENT	Oct 14, 1983	Substantially Equivalent	Worthington Diagnostic Systems
K830331	LIQUID THROMBOPLASTIN REAGENT	Apr 05, 1983	Substantially Equivalent	Helena Laboratories
K811784	SIGMA PROCEDURE #890	Jul 27, 1981	Substantially Equivalent	Sigma Chemical Co.
K810350	THROMBOPLASTIN	Apr 14, 1981	Substantially Equivalent	Pacific Hemostasis
K792031	LANCER COAGENT PT KIT	Nov 05, 1979	Substantially Equivalent	Sherwood Medical Co.
K791022	PROTHROMBIN REFERENCE PLASMA (HUMAN)	Jul 24, 1979	Substantially Equivalent	Pacific Hemostasis
K791023	PROTHROMBIN FREE BEEF PLASMA (PFB)	Jun 28, 1979	Substantially Equivalent	Pacific Hemostasis
K780203	THROMBOPLASTIN DRIED	Mar 27, 1978	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories