Product Code: GFO FDA class 2 21 CFR 864.7925

Activated Partial Thromboplastin

Hematology

Activated Partial Thromboplastin (product code GFO) is a hematology reagent used in the activated partial thromboplastin time (aPTT) test, a coagulation assay that evaluates the intrinsic and common coagulation pathways to detect clotting factor deficiencies and monitor anticoagulant therapy. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7925 in the Hematology specialty (HE), it is eligible for third-party review.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: GFO
Device Class: FDA class 2
Regulation Number: 864.7925
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 52 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253957	HemosIL Silica Clotting Time	Jan 09, 2026	Substantially Equivalent	Instrumentation Laboratory (IL) Co.
K193556	Cryocheck Hex LA	Oct 23, 2020	Substantially Equivalent	Precision Biologic
K160445	HemosIL Silica Clotting Time	Mar 16, 2016	Substantially Equivalent	Instrumentation Laboratory CO
K053111	STA-CEPHASCREEN KIT	May 04, 2006	Substantially Equivalent	Diagnostica Stago, Inc.
K060688	HEMOSIL SYNTHASIL	Apr 13, 2006	Substantially Equivalent	Instrumentation Laboratory CO
K050221	HEMOSIL SILICA CLOTTING TIME	Mar 30, 2005	Substantially Equivalent	Instrumentation Laboratory CO
K022021	VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT	Nov 01, 2002	Substantially Equivalent	Vital Scientific N.V.
K014028	CARESIDE APTT	Feb 08, 2002	Substantially Equivalent	Careside Hemotology, Inc.
K014008	HEMOCHRON JR. CITRATE APTT CUVETTE	Jan 24, 2002	Substantially Equivalent	Itc, Inc.
K992712	SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334	Dec 06, 1999	Substantially Equivalent	Sigma Diagnostics, Inc.
K992711	SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094	Dec 06, 1999	Substantially Equivalent	Sigma Diagnostics, Inc.
K972831	HEMOCHRON CITRATE APTT	Nov 20, 1997	Substantially Equivalent	International Technidyne Corp.
K973306	IL TEST APTT-SP	Nov 04, 1997	Substantially Equivalent	Instrumentation Laboratory CO
K961892	SPECKTIN-LA TEST SET	Mar 07, 1997	Substantially Equivalent	Analytical Control Systems, Inc.
K955638	SYNTHAFAX APTT REAGENT	Apr 23, 1996	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K955450	PATHROMTIN SL	Apr 19, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K953981	SYNTHASIL APTT REAGENT	Nov 30, 1995	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K935169	APTT-ES	Dec 02, 1994	Substantially Equivalent	Helena Laboratories
K934351	APTT-ES REAGENT	Dec 06, 1993	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K932011	PATHROMTIN	Oct 25, 1993	Substantially Equivalent	Behring Diagnostics, Inc.
K926012	ACS APCT REAGENT, MODIFIED	Apr 27, 1993	Substantially Equivalent	Analytical Control Systems, Inc.
K924637	HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT	Jan 27, 1993	Substantially Equivalent	International Technidyne Corp.
K924638	HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT	Jan 14, 1993	Substantially Equivalent	International Technidyne Corp.
K923731	STACLOT LA TEST KIT	Dec 23, 1992	Substantially Equivalent	American Bioproducts Co.
K921396	PLATELIN L	Oct 19, 1992	Substantially Equivalent	Organon Teknika Corp.
K921223	ACS FREEZE-DRIED APTT REAGENT	Aug 18, 1992	Substantially Equivalent	Analytical Control Systems, Inc.
K921118	ACS APCT REAGENT	Jul 28, 1992	Substantially Equivalent	Analytical Control Systems, Inc.
K915418	ELLAGIC ACID APTT REAGENT	Feb 14, 1992	Substantially Equivalent	Helena Laboratories
K915344	HEMOCHRON ONESTEP APTT TEST	Feb 11, 1992	Substantially Equivalent	International Technidyne Corp.
K911994	HEMOCHRON(R) APTT, MODIFICATION	Jul 17, 1991	Substantially Equivalent	International Technidyne Corp.
K903531	ANTICARDIOLIPIN ANTIBODY TEST SYSTEM	Jan 25, 1991	Substantially Equivalent	Medical Innovations Corp.
K905301	THE THERATEST ACA TEST	Jan 14, 1991	Substantially Equivalent	Theratest Laboratories, Inc.
K904341	APTT REAGENT	Nov 08, 1990	Substantially Equivalent	Sigma Chemical Co.
K902556	ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST	Aug 06, 1990	Substantially Equivalent	Analytical Control Systems, Inc.
K900049	APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT	Jan 25, 1990	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K896545	ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT)	Dec 01, 1989	Substantially Equivalent	Sigma Chemical Co.
K895255	APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT	Oct 06, 1989	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K892209	APTT BY HEMOCHRON(R)	Jun 22, 1989	Substantially Equivalent	Intensive Technology, Inc.
K891015	COAG-1 APTT TEST CARD	May 22, 1989	Substantially Equivalent	Cardiovascular Diagnostic Services
K891337	THROMBOSCREEN APTT REAGENT	Apr 21, 1989	Substantially Equivalent	Pacific Hemostasis
K890859	EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME	Apr 21, 1989	Substantially Equivalent	Elite Diagnostic , Ltd.
K890619	EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT	Mar 15, 1989	Substantially Equivalent	Elite Diagnostic , Ltd.
K890052	BIOTRACK APTT REAGENT CARTRIDGE	Feb 24, 1989	Substantially Equivalent	Biotrack, Inc.
K884856	APTT REAGENT	Jan 30, 1989	Substantially Equivalent	Precision Biologicals, Inc.
K884702	EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629	Jan 27, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K884485	KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT	Dec 28, 1988	Substantially Equivalent	King Diagnostics, Inc.
K882325	UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST	Aug 25, 1988	Substantially Equivalent	Sclavo, Inc.
K881068	CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST	Mar 23, 1988	Substantially Equivalent	Creative Laboratory Products, Inc.
K820835	ALUMINA SILICA-ACTIVATED PARTIAL THROM	Apr 26, 1982	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K781104	PLASMA COAGULATION CONT., ABNORMAL	Aug 10, 1978	Substantially Equivalent	Ortho Diagnostics, Inc.
K760918	HEPARIN CONTROL PLASMA	Jan 10, 1977	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K760318	ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT	Aug 03, 1976	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.