Product Code: DAP FDA class 2 21 CFR 864.7320

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Hematology

This is an immunological reagent kit for detecting fibrinogen and its degradation products (fibrin split products), which accumulate in conditions such as disseminated intravascular coagulation (DIC) and are used as markers of fibrinolysis and coagulation disorders. The kit includes antigen, antiserum, and control components for use in hematology laboratories. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAP, regulated under 21 CFR 864.7320, within the Hematology medical specialty.

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FEI Numbers

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Basic Information

Product Code: DAP
Device Class: FDA class 2
Regulation Number: 864.7320
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 57 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K172903	HemosIL D-Dimer HS 500	Nov 22, 2017	Substantially Equivalent	Instrumentation Laboratory CO
K162227	STA® - Liatest® D-Di	Dec 10, 2016	Substantially Equivalent	Diagnostica Stago
K160885	HemosIL D-Dimer HS	Oct 27, 2016	Substantially Equivalent	Instrumentation Laboratory CO
K151534	HemosIL D-Dimer HS	Jul 06, 2015	Substantially Equivalent	Instrumentation Laboratory CO
K141144	STA LIATEST D-DI	Sep 03, 2014	Substantially Equivalent	Diagnostica Stago
K112818	VIDAS D-DIMER EXCLUSION II (DEX2)	Jul 31, 2012	Substantially Equivalent	bioMerieux, Inc.
K110303	STRATUS CS ACUTE CARE D-DIMER	May 16, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics
K093626	INNOVANCE D-DIMER, MODEL OPBP09	Nov 29, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K090264	HEMOSIL D-DIMER HS 500, CONTROLS	Feb 05, 2010	Substantially Equivalent	Instrumentation Laboratory CO
K091916	INNOVANCE D-DIMER, MODEL OPBP09	Oct 29, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K081732	INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS	Oct 24, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics
K073042	HEMOSIL D-DIMER	Jul 31, 2008	Substantially Equivalent	Instrumentation Laboratory
K080069	DIMERTEST	Feb 13, 2008	Substantially Equivalent	American Diagnostica, Inc.
K070927	HEMOSIL D-DIMER HS	Sep 17, 2007	Substantially Equivalent	Instrumentation Laboratory CO
K063356	STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK	Mar 23, 2007	Substantially Equivalent	Dade Behring, Inc.
K051597	STRATUS CS D-DIMER	Aug 17, 2005	Substantially Equivalent	Dade Behring, Inc.
K050544	HEMOSIL D-DIMER HS	Apr 26, 2005	Substantially Equivalent	Instrumentation Laboratory CO
K050278	HEMOSIL D-DIMER	Mar 10, 2005	Substantially Equivalent	Instrumentation Laboratory CO
K042723	TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300	Dec 07, 2004	Substantially Equivalent	Biosite Incorporated
K033491	ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS	Sep 01, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K041438	ADVANCED D-DIMER ASSAY	Aug 11, 2004	Substantially Equivalent	Dade Behring, Inc.
K040437	TRIAGE PROFILER S.O.B. PANEL	Jun 25, 2004	Substantially Equivalent	Biosite Incorporated
K040882	VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442	Jun 10, 2004	Substantially Equivalent	bioMerieux, Inc.
K032419	QUANTEX D-DIMER	Oct 24, 2003	Substantially Equivalent	Instrumentation Laboratory CO
K030328	VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442	Sep 02, 2003	Substantially Equivalent	bioMerieux, Inc.
K030687	K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C	Jun 27, 2003	Substantially Equivalent	Kamiya Biomedical Co.
K022976	STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D	Jan 16, 2003	Substantially Equivalent	Dade Behring, Inc.
K022977	STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C	Nov 27, 2002	Substantially Equivalent	Dade Behring, Inc.
K020810	VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442	Oct 03, 2002	Substantially Equivalent	bioMerieux, Inc.
K012755	AUTODIMER ASSAY MODEL # 1431	Mar 15, 2002	Substantially Equivalent	Xtrana, Inc.
K013549	SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971	Dec 26, 2001	Substantially Equivalent	Sigma Diagnostics, Inc.
K013545	SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221	Nov 15, 2001	Substantially Equivalent	Sigma Diagnostics, Inc.
K013544	SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096	Nov 15, 2001	Substantially Equivalent	Sigma Diagnostics, Inc.
K002948	K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT	May 18, 2001	Substantially Equivalent	Kamiya Biomedical Co.
K002706	ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI	Mar 16, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K003267	SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A	Mar 15, 2001	Substantially Equivalent	Sigma Diagnostics, Inc.
K002642	MINIQUANT D-DIMER, MODEL 1447	Feb 05, 2001	Substantially Equivalent	Biopool Intl., Inc.
K000492	MDA D-DIMER	Jun 07, 2000	Substantially Equivalent	Organon Teknika Corp.
K992957	ADVANCED D-DIMER	Jan 28, 2000	Substantially Equivalent	Dade Behring, Inc.
K974596	DIMERTEST LATEX ASSAY	May 26, 1998	Substantially Equivalent	Agen Biomedical , Ltd.
K974776	MDA D-DIMER	Apr 16, 1998	Substantially Equivalent	Organon Teknika Corp.
K973819	VIDAS D-DIMER (DD) ASSAY	Mar 10, 1998	Substantially Equivalent	Biomerieux Vitek, Inc.
K972696	IL TEST D-DIMER	Nov 04, 1997	Substantially Equivalent	Instrumentation Laboratory CO
K964728	STA-LIATEST D-DI TEST KIT	Jun 26, 1997	Substantially Equivalent	American Bioproducts Co.
K964718	STA D-DI CALIBRATOR KIT	May 23, 1997	Substantially Equivalent	American Bioproducts Co.
K943571	MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS	Jun 15, 1995	Substantially Equivalent	More Diagnostics
K943787	AURATEK FDP	Sep 20, 1994	Substantially Equivalent	Organon Teknika Corp.
K932657	FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2	Nov 02, 1993	Substantially Equivalent	More Diagnostics
K915698	FIBRINOSTIKA TDP MICROELISA SYSTEM	Aug 05, 1992	Substantially Equivalent	Organon Teknika Corp.
K920943	FDP PLASMA TEST KIT	Jul 13, 1992	Substantially Equivalent	American Bioproducts Co.
K915203	D-DIMER WELLCOTEST (HA10)	Jan 31, 1992	Substantially Equivalent	Wellcome Diagnostics
K915503	FIBRINOGEN FDP CONTROL	Jan 30, 1992	Substantially Equivalent	Cala Diagnostics
K912876	FIBRINOSTIKA FBDP MICROELISA SYSTEM	Oct 09, 1991	Substantially Equivalent	Organon Teknika Corp.
K890189	AGEN DIMERTEST EIA	Mar 03, 1989	Substantially Equivalent	Agen Biomedical , Ltd.
K882944	DIMERTEST(R) LATEX	Aug 17, 1988	Substantially Equivalent	Agen Biomedical , Ltd.
K872195	DATA-FI DIMERTEST LATEX ASSAY	Aug 06, 1987	Substantially Equivalent	American Dade
K862156	ASSERACHROM D-DI KIT	Sep 16, 1986	Substantially Equivalent	American Bioproducts Co.