Product Code: GGC FDA class 2 21 CFR 864.5425

Control, Plasma, Abnormal

Hematology

Control, Plasma, Abnormal (product code GGC) is a quality control material containing plasma with abnormal coagulation characteristics, used to verify the accuracy and precision of coagulation assays in clinical hematology laboratories. This device is classified as FDA Class 2, indicating moderate risk, and does not require premarket notification under the current classification. Regulated under 21 CFR 864.5425 in the Hematology specialty (HE), this device carries no flags for implantation, life support, GMP exemption, or third-party review.

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FEI Numbers

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Basic Information

Product Code: GGC
Device Class: FDA class 2
Regulation Number: 864.5425
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 4

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 40 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K102552	HEMOSIL LA POSITIVE CONTROL	Apr 05, 2011	Substantially Equivalent	Instrumentation Laboratory CO
K100103	SPECIALTY ASSAYED CONTROL-2	Dec 15, 2010	Substantially Equivalent	Helena Laboratories
K062306	PLASMACON N, PLASMACON L-1, PLASMACON L-2	Mar 16, 2007	Substantially Equivalent	R2 Diagnostics, Inc.
K061803	STA - CONTROL LA 1+2	Jul 28, 2006	Substantially Equivalent	Diagnostica Stago, Inc.
K032804	CRYOCHECK WEAK LUPUS POSITIVE CONTROL	Nov 03, 2003	Substantially Equivalent	Precision Biologic
K023312	CONTROL PLASMA P	Nov 01, 2002	Substantially Equivalent	Dade Behring, Inc.
K020878	LYPHOCHEK HEMOSTASIS, MODELS 798, 799	Apr 15, 2002	Substantially Equivalent	Bio-Rad
K020109	SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL	Feb 06, 2002	Substantially Equivalent	Sigma Diagnostics, Inc.
K012422	K-ASSAY D-DIMER CONTROLS	Aug 21, 2001	Substantially Equivalent	Kamiya Biomedical Co.
K003329	SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217	Mar 01, 2001	Substantially Equivalent	Sigma Diagnostics, Inc.
K993332	GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05	Feb 16, 2000	Substantially Equivalent	Gradipore , Ltd.
K984131	COAGULATION CONTROL LEVEL 3 (ABNORMAL)	Dec 01, 1998	Substantially Equivalent	Pacific Hemostasis
K984130	COAGULATION CONTROL LEVEL 2 (ABNORMAL)	Dec 01, 1998	Substantially Equivalent	Pacific Hemostasis
K961370	LA POSITIVE CONTROL PLASMA	May 24, 1996	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K955040	AT-III CONTROL PLASMA KIT	Jan 31, 1996	Substantially Equivalent	American Bioproducts Co.
K952623	CRYO CHECK LUPUS PLASMA	Nov 06, 1995	Substantially Equivalent	Precision Biologicals, Inc.
K952624	CRYO CHECK ABNORMAL REFERENCE CHECK I & II	Oct 30, 1995	Substantially Equivalent	Precision Biologicals, Inc.
K945856	POSITIVE LUPUS ANTICOAGULANT PLASMA	Oct 05, 1995	Substantially Equivalent	George King Bio-Medical, Inc.
K952338	STA-COAG CONTROL [P] PLUS KIT	Sep 21, 1995	Substantially Equivalent	American Bioproducts Co.
K941872	SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302	Nov 21, 1994	Substantially Equivalent	Helena Laboratories
K930267	BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL	Mar 22, 1994	Substantially Equivalent	Biomerieux Vitek, Inc.
K924402	CONTROL PLASMA U	Feb 22, 1994	Substantially Equivalent	Behring Diagnostics, Inc.
K924401	PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)	Feb 22, 1994	Substantially Equivalent	Behring Diagnostics, Inc.
K930959	FACTOR CONTROL [P]	May 20, 1993	Substantially Equivalent	American Bioproducts Co.
K930923	COAG-CONTROL	Apr 27, 1993	Substantially Equivalent	American Bioproducts Co.
K924405	CONTROL PLASMA P	Dec 01, 1992	Substantially Equivalent	Behring Diagnostics, Inc.
K921665	AVK CONTROL I & II	Jun 09, 1992	Substantially Equivalent	American Bioproducts Co.
K911885	DADE(R) PROTEIN C ABNORMAL CONTRAL	Jun 11, 1991	Substantially Equivalent	Baxter Healthcare Corp
K904073	COAGULATION REFERENCE PLASMA, ABNORMAL	Oct 22, 1990	Substantially Equivalent	Medi-Tech, Inc.
K901233	ORTHO ABNORMAL PROTEIN C CONTROL PLASMA	Apr 11, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K900782	HEPARIN CONTROL PLASMA, FOR USE IN APTT	Mar 27, 1990	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K895261	ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)	Oct 06, 1989	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K895260	ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)	Oct 06, 1989	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K894425	ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III	Aug 03, 1989	Substantially Equivalent	Analytical Control Systems, Inc.
K894338	ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III	Jul 25, 1989	Substantially Equivalent	Analytical Control Systems, Inc.
K893971	ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II	Jul 25, 1989	Substantially Equivalent	Analytical Control Systems, Inc.
K893970	ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II	Jul 25, 1989	Substantially Equivalent	Analytical Control Systems, Inc.
K881510	CLP ABNORMAL COAGULATION CONTROL	May 06, 1988	Substantially Equivalent	Creative Laboratory Products, Inc.
K871420	HERPES 1 AND 2 MICROASSAYS	Dec 11, 1987	Substantially Equivalent	Diamedix Corp.
K770188	HPC TM (HEPARINIZED PLASMA CONTROL)	Feb 18, 1977	Substantially Equivalent	Bio/Data Corp.