Product Code: KFF FDA class 2 21 CFR 864.7525

Assay, Heparin

Hematology

Heparin Assay is an in vitro diagnostic device used to measure heparin concentration in patient blood samples, enabling monitoring of anticoagulation therapy in patients receiving heparin for the prevention or treatment of thrombosis and related conditions. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KFF, regulated under 21 CFR 864.7525, within the Hematology medical specialty. This device is eligible for third-party review.

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FEI Numbers

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Basic Information

Product Code: KFF
Device Class: FDA class 2
Regulation Number: 864.7525
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 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K213464	HemosIL Liquid Anti-Xa	Oct 04, 2022	Substantially Equivalent	Instrumentation Laboratory CO
K162540	INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls	Aug 22, 2017	Substantially Equivalent	Siemens Healthcare Diagnostics Prodcts GmbH
K111822	STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH	Oct 26, 2011	Substantially Equivalent	Diagnostica Stago, Inc.
K090209	HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS	Jun 02, 2009	Substantially Equivalent	Instrumentation Laboratory CO
K050367	BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6	May 24, 2006	Substantially Equivalent	Hyphen Biomed
K013305	ENOXAPARIN TEST CARD	Aug 23, 2002	Substantially Equivalent	Cardiovascular Diagnostics, Inc.
K013637	ACTICHROME HEPARIN (ANTI-FIIA)	Apr 16, 2002	Substantially Equivalent	American Diagnostica, Inc.
K013318	ACTICHROME HEPARIN (ANTI-FXA), MODEL 832	Mar 08, 2002	Substantially Equivalent	American Diagnostica, Inc.
K010455	ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN	Jun 07, 2001	Substantially Equivalent	Diagnostica-Stago
K010193	HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS	Jun 06, 2001	Substantially Equivalent	International Technidyne Corp.
K983178	COAMATIC HEPARIN	Nov 03, 1998	Substantially Equivalent	Instrumentation Laboratory CO
K980242	IL TEST HEPARIN	Mar 19, 1998	Substantially Equivalent	Instrumentation Laboratory CO
K972209	SPECTROLYSE HEPARIN (ANTI-IIA)	Aug 12, 1997	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K965076	MDA HEPARIN ANTI-X ASSAY	Mar 18, 1997	Substantially Equivalent	Organon Teknika Corp.
K952667	CHROM Z-HEPARIN, CAT. NO 5242	Feb 14, 1996	Substantially Equivalent	Helena Laboratories
K952514	COACUTE HEPARIN	Nov 20, 1995	Substantially Equivalent	Chromogenix AB
K943520	HEPARIN CONTROL KIT	Sep 26, 1995	Unknown	American Bioproducts Co.
K943519	HBPM/LMWH CONTROL KIT	Sep 26, 1995	Unknown	American Bioproducts Co.
K943514	THE HEPANORM HBPM/LMWH KIT	Sep 26, 1995	Unknown	American Bioproducts Co.
K943516	ROTACHROM HBPM/LMWH TEST KIT	Aug 31, 1995	Substantially Equivalent	American Bioproducts Co.
K943515	ROTACHROM HEPARIN TEST KIT	Aug 31, 1995	Substantially Equivalent	American Bioproducts Co.
K925433	THE STACHROM HEPARIN ASSAY KIT	May 23, 1995	Substantially Equivalent	American Bioproducts Co.
K943517	STACLOT HEPARIN TEST KIT	May 11, 1995	Substantially Equivalent	American Bioproducts Co.
K943283	HEPARIN MANAGEMENT TEST CARD; HMT CARD	May 10, 1995	Substantially Equivalent	Cardiovascular Diagnostics, Inc.
K934274	HEMOLAB HEPARICHROM ASSAY	May 06, 1994	Substantially Equivalent	Biomerieux Vitek, Inc.
K935212	IL TEST HEPARIN (XA), PN 84699-15	Feb 07, 1994	Substantially Equivalent	Instrumentation Laboratory CO
K923499	SPECTROLYSE HEPARIN KIT	Jan 27, 1994	Substantially Equivalent	Biopool AB
K925200	BERICHROM HEPARIN	Jun 28, 1993	Substantially Equivalent	Behring Diagnostics, Inc.
K910181	HITT BY HEMOCHRON(R)	May 10, 1991	Substantially Equivalent	International Technidyne Corp.
K910741	HEPARIN CONTROLS, HIGH AND LOW	Apr 29, 1991	Substantially Equivalent	Sigma Diagnostics, Inc.
K904003	HEMOCHRON(R) HEPARIN RESPONSE TEST	Nov 29, 1990	Substantially Equivalent	Intensive Technology, Inc.
K903841	ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA	Oct 22, 1990	Substantially Equivalent	Organon Teknika Corp.
K901874	COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY	Jul 20, 1990	Substantially Equivalent	Kabi Diagnostica
K900396	ORTHOKROME* HEPARIN	Mar 15, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K884590	HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES	Jan 10, 1989	Substantially Equivalent	Hemotec, Inc.
K864211	IL TEST 97575-15, HEPARIN ASSAY	Jan 05, 1987	Substantially Equivalent	Instrumentation Laboratory CO
K854762	HEPANORM CALIBRATION PLASMA SET	Mar 03, 1986	Substantially Equivalent	American Bioproducts Co.
K853239	HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY	Nov 05, 1985	Substantially Equivalent	Haemachem, Inc.
K850486	GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY	May 08, 1985	Substantially Equivalent	Warner-Lambert Co.
K843202	HEPARIN CALIBRATOR ACA	Nov 30, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K843201	HEPARIN ACA ANALYTICAL TEST PACK	Nov 30, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K834024	HEPARINOMETER	Jun 11, 1984	Substantially Equivalent	Western Laboratories Corp.
K833891	COATEST HEPARIN	Jan 30, 1984	Substantially Equivalent	Kabivitrum, Inc.
K832373	DIACROM * HEPARIN	Sep 29, 1983	Substantially Equivalent	Wellcome Diagnostics
K812424	CI-TROL HEPARIN CONTROLS, LOW/HIGH	Oct 02, 1981	Substantially Equivalent	American Dade
K781479	HEPARIN ASSAY	Feb 15, 1979	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.