Product Code: JBQ FDA class 2 21 CFR 864.7060

Antithrombin Iii Quantitation

Hematology

An antithrombin III quantitation test is a laboratory assay used to measure the concentration or activity of antithrombin III in plasma, a natural anticoagulant protein whose deficiency is associated with increased risk of venous thromboembolism. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JBQ, regulated under 21 CFR 864.7060, within the Hematology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: JBQ
Device Class: FDA class 2
Regulation Number: 864.7060
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 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K242952	INNOVANCE Antithrombin	Mar 28, 2025	Substantially Equivalent	Siemens Healthcare Diagnostic Products GmbH
K081769	INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5	May 28, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K070301	HEMOSIL ANTITHROMBIN	Feb 23, 2007	Substantially Equivalent	Instrumentation Laboratory CO
K062431	HEMOSIL LIQUID ANTITHROMBIN	Sep 01, 2006	Substantially Equivalent	Instrumentation Laboratory CO
K043007	BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105	Nov 07, 2005	Substantially Equivalent	Hyphen Biomed
K033775	HEMOSIL LIQUID ANTITHROMBIN XL	Jan 02, 2004	Substantially Equivalent	Instrumentation Laboratory CO
K023991	CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50	Apr 28, 2003	Substantially Equivalent	Precision Biologic
K022550	COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS	Aug 27, 2002	Substantially Equivalent	Instrumentation Laboratory CO
K022195	COAMATIC AT-400	Aug 07, 2002	Substantially Equivalent	Instrumentation Laboratory CO
K994238	IL TEST LIQUID ANTITHROMBIN	Jun 23, 2000	Substantially Equivalent	Instrumentation Laboratory CO
K000361	K-ASSAY AT-III	Apr 26, 2000	Substantially Equivalent	Kamiya Biomedical Co.
K980499	IL TEST ANTITHROMBIN	Apr 02, 1998	Substantially Equivalent	Instrumentation Laboratory CO
K974110	IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT	Dec 24, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K972144	SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III	Jul 25, 1997	Substantially Equivalent	Sigma Diagnostics, Inc.
K960871	SPECTROLYSE ANTITHROMBIN III (ANTI-XA)	Aug 14, 1996	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K952515	COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY	Jan 23, 1996	Substantially Equivalent	Chromogenix AB
K951943	CHROM Z CHROMOGENIC ASSAYS	Nov 13, 1995	Substantially Equivalent	Helena Laboratories
K944279	AT-III CALIBRATOR	Apr 07, 1995	Substantially Equivalent	American Bioproducts Co.
K934156	BIOMERIEUX HEMOLAB AT III	Dec 22, 1994	Substantially Equivalent	Biomerieux Vitek, Inc.
K935308	ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY	May 17, 1994	Substantially Equivalent	Sigma Diagnostics, Inc.
K936196	ANTITHROMBIN III CHROMOGENIC ASSAY	May 04, 1994	Substantially Equivalent	Baxter Diagnostics, Inc.
K931420	COATEST(R) ANTITHROMBIN III, MODIFICATION	May 02, 1994	Substantially Equivalent	Kabi Pharmacia Hepar, Inc.
K915083	COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY	Jan 03, 1992	Substantially Equivalent	Kabi Pharmacia, Inc.
K913667	ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT	Jan 03, 1992	Substantially Equivalent	The Binding Site, Ltd.
K905110	LIATEST(R) AT III TEST KIT	Jan 24, 1991	Substantially Equivalent	American Bioproducts Co.
K902393	COACUTE ANTITHROMBIN CHROMOGENIC ASSAY	Sep 25, 1990	Substantially Equivalent	Kabi Diagnostica
K902530	SPECTROLYSE ATIII KIT	Aug 09, 1990	Substantially Equivalent	Biopool AB
K901977	BECKMAN ANTITHROMBIN III REAGENT KIT	Aug 06, 1990	Substantially Equivalent	Beckman Instruments, Inc.
K900400	ORTHOKROME* ANTITHROMBIN	Mar 15, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K893608	ACTICHROME ATIII KIT	Jun 23, 1989	Substantially Equivalent	American Diagnostic Corp.
K884144	TURBOX ANTITHROMBIN III	Dec 20, 1988	Substantially Equivalent	Unipath , Ltd.
K883662	BERICHROM(R) ANTITHROMBIN III	Nov 23, 1988	Substantially Equivalent	Behring Diagnostics, Inc.
K880700	ENZYGNOST(R) TAT REAGENTS	Apr 27, 1988	Substantially Equivalent	Behring Diagnostics, Inc.
K880315	DADE ANTITHROMBIN III CHROMOGENIC ASSAY	Mar 16, 1988	Substantially Equivalent	Baxter Healthcare Corp
K864214	IL TEST 97574-15M, ANTITTHROMBIN III ASSASY	Nov 25, 1986	Substantially Equivalent	Instrumentation Laboratory CO
K850412	GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY	May 08, 1985	Substantially Equivalent	Warner-Lambert Co.
K841736	IL TEST ANTITHROMBIN III ACTIVITY	Sep 06, 1984	Substantially Equivalent	Instrumentation Laboratory CO
K832592	DIACROM * ATIII	Sep 29, 1983	Substantially Equivalent	Wellcome Diagnostics
K832268	RABBIT ANTI-HUMAN ANTITHROMBIN III	Aug 12, 1983	Substantially Equivalent	Gelco Diagnostics, Inc.
K831961	IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN	Aug 11, 1983	Substantially Equivalent	Kent Laboratories, Inc.
K831297	PROTOTRO/PROTEOLYTIC ENZYME CONTROL	Jun 08, 1983	Substantially Equivalent	American Dade
K812829	COATEST ANTITHROMBIN	Dec 30, 1981	Substantially Equivalent	Kabivitrum, Inc.
K812626	ACA ANTITHROMBIN III PLASMINOGEN CALIB	Nov 24, 1981	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K812627	ACA ANTITHROMBIN III TEST PACK	Oct 08, 1981	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K812215	ANTITHROMBIN III SCREEN KIT	Sep 01, 1981	Substantially Equivalent	Pacific Hemostasis
K802912	HELENA AT-III QUIPLATE PROCEDURE	Dec 22, 1980	Substantially Equivalent	Helena Laboratories
K792019	PHADECODE XA INHIBITOR ASSAY	Nov 05, 1979	Substantially Equivalent	Pharmaseal Div., Baxter Healthcare Corp.
K790090	DETERMINATION OF ANTITHROMBIN III, 885	Feb 26, 1979	Substantially Equivalent	Sigma Chemical Co.
K781860	ASSAY, CHROMOGENIC ANTITHROMBIN III	Dec 04, 1978	Substantially Equivalent	Ortho Diagnostics, Inc.
K781480	ANTITHROMBIN III ASSAY	Nov 08, 1978	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K781026	ANTITHROMBIN III SERUM, ANTI-HUMAN	Aug 10, 1978	Substantially Equivalent	Icl Scientific
K772328	LAS-R HUMAN ANTITHROMBIN III TEST	Feb 03, 1978	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K780002	ANTITHROMBIN III ASSAY	Jan 31, 1978	Substantially Equivalent	Ortho Diagnostics, Inc.
K771669	DIAG. KIT FOR TOTAL ANTITHROMBIN III	Nov 09, 1977	Substantially Equivalent	Abbott Laboratories
K770942	PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY	Jul 21, 1977	Substantially Equivalent	Pharmaseal Div., Baxter Healthcare Corp.
K770394	THROMBO-SCREEN AT-111 KIT	Mar 30, 1977	Substantially Equivalent	Bay Area Hema. Onco. Clinic. & Res. L