Product Code: GGN FDA class 2 21 CFR 864.5425

Plasma, Coagulation Control

Hematology

Plasma, Coagulation Control (product code GGN) is a quality control plasma preparation used to assess the performance of coagulation testing systems and ensure the accuracy of clotting 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: GGN
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 99 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K170864	VALIDATE D-Dimer Calibration Verification / Linearity Test Kit	Jun 21, 2017	Substantially Equivalent	Maine Standards Company, LLC
K163498	VALIDATE Heparin Calibration Verification/Linearity Test Kit	Mar 16, 2017	Substantially Equivalent	Maine Standards Company, LLC
K161316	George King Coumadin Plasma	Feb 23, 2017	Substantially Equivalent	George King Bio-Medical, Inc.
K162705	VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit	Jan 05, 2017	Substantially Equivalent	Maine Standards Company, LLC
K152961	VALIDATE D-Dimer Calibration Verification/Linearity Test Kit	Jun 03, 2016	Substantially Equivalent	Maine Standards Company, LLC
K150144	VisuCon-F Low Fibrinogen Control Plasma	Mar 06, 2016	Substantially Equivalent	Affinity Biologicals, Inc.
K142132	POOL NORM	Dec 12, 2014	Substantially Equivalent	Diagnostics Stago S.A.S.
K133582	HEMOSIL D-DIMER HS 500 CONTROL	Aug 15, 2014	Substantially Equivalent	Instrumentation Laboratory
K120977	DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC	Jul 03, 2013	Substantially Equivalent	International Technidyne Corp.
K120900	I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2	May 31, 2013	Substantially Equivalent	Cliniqa Corporation
K120014	STA- COAG CONTROL (N+ABN) PLUS	Mar 14, 2013	Substantially Equivalent	Diagnostica Stago, Inc.
K113211	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	Jan 04, 2012	Substantially Equivalent	Instrumentation Laboratory CO
K110432	VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN	Oct 20, 2011	Substantially Equivalent	Affinity Biologicals, Inc.
K100716	AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5	Jun 23, 2011	Substantially Equivalent	Aalto Scientific, Ltd.
K093848	PT-MULTI-CALIBRATOR, MODEL OPAT07	Dec 20, 2010	Substantially Equivalent	Dade Behring, Inc.
K103314	CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL	Dec 03, 2010	Substantially Equivalent	Medtronic, Inc.
K103313	HEPARIN ASSAY CONTROLS	Dec 01, 2010	Substantially Equivalent	Medtronic, Inc.
K091284	VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA	Oct 28, 2009	Substantially Equivalent	Affinity Biologicals, Inc.
K090563	HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)	Oct 09, 2009	Substantially Equivalent	Instrumentation Laboratory CO
K082859	HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED	Dec 19, 2008	Substantially Equivalent	Instrumentation Laboratory CO
K071319	I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02	Jun 26, 2007	Substantially Equivalent	Bio-Rad, Diagnostics Grp.
K062840	TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS	Mar 01, 2007	Substantially Equivalent	Biosite Incorporated
K063823	COAGUCHEK XS PT CONTROLS	Jan 29, 2007	Substantially Equivalent	Roche Diagnostics Corp.
K052697	HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL	Jan 04, 2006	Substantially Equivalent	Akers Biosciences, Inc.
K051472	BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR	Dec 23, 2005	Substantially Equivalent	Hyphen Biomed
K050799	TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS	Jun 29, 2005	Substantially Equivalent	Biosite Incorporated
K043451	BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR	Mar 17, 2005	Substantially Equivalent	Hyphen Biomed
K042760	PEFAKIT APC-R FACTOR V LEIDEN CONTROLS	Dec 22, 2004	Substantially Equivalent	Pentapharm , Ltd.
K042333	CONTROL PLASMA N, PROC CONTROL PLASMA	Dec 01, 2004	Substantially Equivalent	Dade Behring, Inc.
K042209	CONTROL PLASMA N AND CONTROL PLASMA P	Oct 21, 2004	Substantially Equivalent	Dade Behring, Inc.
K042206	PURPLE/BLACK HEPARIN ASSAY CONTROL	Oct 18, 2004	Substantially Equivalent	Medtronic Vascular
K042175	HEPARINASE HR ACT CONTROL, MODEL 550-12	Oct 18, 2004	Substantially Equivalent	Medtronic Vascular
K040275	LYPHOCHEK HEMOSTASIS CONTROL	Feb 27, 2004	Substantially Equivalent	Bio-Rad
K032611	LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743	Sep 17, 2003	Substantially Equivalent	Bio-Rad
K032017	LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3	Aug 08, 2003	Substantially Equivalent	Bio-Rad
K030965	CONTROL PLASMA LMW HEPARIN	Jun 06, 2003	Substantially Equivalent	Instrumentation Laboratory CO
K030182	LIQUICHEK D-DIMER CONTROL, MODEL 356, 357	Feb 24, 2003	Substantially Equivalent	Bio-Rad
K022046	VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL	Jul 23, 2002	Substantially Equivalent	Vital Scientific N.V.
K021024	HEMOSIL HIGH ABNORMAL CONTROL ASSAYED	May 16, 2002	Substantially Equivalent	Instrumentation Laboratory CO
K021023	HEMOSIL NORMAL CONTROL (ASSAYED); HEMOSIL NORMAL CONTROL 1 (UNASSAYED)	May 14, 2002	Substantially Equivalent	Instrumentation Laboratory CO
K021022	HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)	May 14, 2002	Substantially Equivalent	Instrumentation Laboratory CO
K012722	LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783	Sep 18, 2001	Substantially Equivalent	Bio-Rad
K010750	PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560	Sep 07, 2001	Substantially Equivalent	Fisher Diagnostics
K010350	STA -CALIBRATOR HBPM/LMWH KIT	Apr 09, 2001	Substantially Equivalent	Diagnostica Stago, Inc.
K010324	STA-QUALITY HBPM/LMWH KIT	Apr 09, 2001	Substantially Equivalent	Diagnostica Stago, Inc.
K000679	THROMBOSTRATE CONTROL PLASMAS	Mar 24, 2000	Substantially Equivalent	Pacific Hemostasis
K994159	HMP CONTROLS (TAS) RAPIDPOINT	Feb 15, 2000	Substantially Equivalent	Cardiovascular Diagnostics, Inc.
K991439	POLLER CALIBRANTS	Dec 20, 1999	Substantially Equivalent	European Concerted Action on Anticoagulation
K992829	CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3	Nov 22, 1999	Substantially Equivalent	Medical Analysis Systems, Inc.
K992279	HEPARIN CONTROL PLASMA LEVEL 2	Aug 26, 1999	Substantially Equivalent	Pacific Hemostasis
K992278	HEPARIN CONTROL PLASMA LEVEL 1	Aug 26, 1999	Substantially Equivalent	Pacific Hemostasis
K990858	LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789	Apr 21, 1999	Substantially Equivalent	Bio-Rad
K981752	I-STAT COAGULATION CONTROL SET	Jun 15, 1998	Substantially Equivalent	Biopool Intl., Inc.
K981255	SIGMA DIAGNOSTICS ACCUCLOT CONTROL III	Apr 29, 1998	Substantially Equivalent	Sigma Diagnostics, Inc.
K981254	SIGMA DIAGNOSTICS ACCUCLOT CONTROL II	Apr 29, 1998	Substantially Equivalent	Sigma Diagnostics, Inc.
K981248	SIGMA DIAGNOSTICS ACCUCLOT CONTROL I	Apr 29, 1998	Substantially Equivalent	Sigma Diagnostics, Inc.
K981178	THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS	Apr 27, 1998	Substantially Equivalent	Cardiovascular Diagnostics, Inc.
K980982	AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2	Apr 16, 1998	Substantially Equivalent	Avocet Medical, Inc.
K971219	CRYO CHECK INR VALIDATION SET	Aug 29, 1997	Substantially Equivalent	Precision Biologicals, Inc.
K971222	CRYO CHECK APC RESISTANT PLASMA	Aug 19, 1997	Substantially Equivalent	Precision Biologicals, Inc.
K964716	STA LIATEST CONTROL [N]+[P] KIT	Jun 26, 1997	Substantially Equivalent	American Bioproducts Co.
K971428	COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0	Jun 17, 1997	Substantially Equivalent	Pacific Hemostasis
K971748	TAS PT-NCTEST CONTROLS	May 29, 1997	Substantially Equivalent	Cardiovascular Diagnostics, Inc.
K964963	LYPHOCHEK COAGULATION CONTROL	Feb 20, 1997	Substantially Equivalent	Bio-Rad
K962674	STA - VWF CONTROL [N]+[P] KIT	Jul 23, 1996	Substantially Equivalent	American Bioproducts Co.
K961189	TAS A PTT TEST CONTROLS	Jun 05, 1996	Substantially Equivalent	Cardiovascular Diagnostics, Inc.
K960234	TAS HMT CONTROLS	May 30, 1996	Substantially Equivalent	Cardiovascular Diagnostics, Inc.
K955278	BEHRING COAGULATION TIMER	May 30, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K952321	PORCINE FACTOR VIII;C REAGENT	Mar 11, 1996	Substantially Equivalent	Helena Laboratories
K951823	CRYO CHECK LOW FIBRINOGEN CONTROL	Jan 03, 1996	Substantially Equivalent	Precision Biologicals, Inc.
K952622	CRYO CHECK NORMAL HUMAN REFERENCE PLASMA	Oct 30, 1995	Substantially Equivalent	Precision Biologicals, Inc.
K945855	A-FACT, ABNORMAL FACTOR ASSAY CONTROL	Oct 24, 1995	Substantially Equivalent	George King Bio-Medical, Inc.
K945854	B-FACT, BORDERLINE FACTOR ASSAY CONTROL	Oct 24, 1995	Substantially Equivalent	George King Bio-Medical, Inc.
K940209	ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL	May 11, 1995	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K943518	STA SYSTEM CONTROL [N] + [P] KIT	Mar 21, 1995	Substantially Equivalent	American Bioproducts Co.
K944691	ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II	Mar 15, 1995	Substantially Equivalent	International Technidyne Corp.
K941860	SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)	Sep 14, 1994	Substantially Equivalent	Helena Laboratories
K933277	COAGULATION A.R.P.	Mar 22, 1994	Substantially Equivalent	Helena Laboratories
K922887	CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEM	Feb 25, 1993	Substantially Equivalent	Precision Biologicals, Inc.
K924404	CLIBRATION PLASMAS	Dec 01, 1992	Substantially Equivalent	Behring Diagnostics, Inc.
K922174	COAG-CONTROL [N] KIT	Oct 26, 1992	Substantially Equivalent	American Bioproducts Co.
K921344	THROMBO-CALIBRATOR KIT	Jun 09, 1992	Substantially Equivalent	American Bioproducts Co.
K914949	COAGULATION ARPR,CAT.NO.5185	Mar 04, 1992	Substantially Equivalent	Helena Laboratories
K911777	ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED	Aug 22, 1991	Substantially Equivalent	Helena Laboratories
K905673	AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183	Feb 11, 1991	Substantially Equivalent	Helena Laboratories
K902363	COAGULATION CONTROL, LEVEL III	Jul 26, 1990	Substantially Equivalent	Sigma Chemical Co.
K902362	COAGULATION CONTROL, LEVEL II	Jul 26, 1990	Substantially Equivalent	Sigma Chemical Co.
K902361	COAGULATION CONTROL, LEVEL I	Jul 26, 1990	Substantially Equivalent	Sigma Chemical Co.
K902210	ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA	Jul 03, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K900019	ROCKET REFERENCE PLASMA, CAT NO. 5188	Jan 25, 1990	Substantially Equivalent	Helena Laboratories
K884901	DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO	Feb 02, 1989	Substantially Equivalent	Baxter Healthcare Corp
K884854	COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)	Jan 30, 1989	Substantially Equivalent	Precision Biologicals, Inc.
K882481	HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II	Aug 30, 1988	Substantially Equivalent	International Technidyne Corp.
K882480	HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II	Aug 30, 1988	Substantially Equivalent	International Technidyne Corp.
K881348	VERIFY(R) REFERENCE PLASMA	May 02, 1988	Substantially Equivalent	Organon Teknika Corp.
K880302	CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER	Feb 19, 1988	Substantially Equivalent	Hemotec, Inc.
K840288	DIACELIN	Apr 23, 1984	Substantially Equivalent	Diatech, Inc.
K834086	CONTACT-K APTT REAGENT	Feb 03, 1984	Substantially Equivalent	Pacific Hemostasis
K771346	CI-TROL COAGULATION CONTROLS II & III	Aug 22, 1977	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.