Product Code: CGS FDA class 2 21 CFR 862.1215

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Clinical Chemistry

The NAD Reduction/NADH Oxidation, CPK or Isoenzymes test system (product code CGS) is an in-vitro diagnostic device used in clinical chemistry to measure creatine phosphokinase (CPK) and its isoenzymes in serum using an NAD/NADH coupled enzymatic method, supporting the diagnosis of myocardial infarction and muscle disorders. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1215 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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510(k)s

123

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CGS
Device Class: FDA class 2
Regulation Number: 862.1215
Medical Specialty: Clinical Chemistry
Review Panel: CH
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 123 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K191296	Pointe Scientific Creatinine Kinase (CK) Reagent Set	Aug 11, 2020	Substantially Equivalent	Medtest DX
K182702	SEKURE Creatine Kinase Assay	Apr 17, 2019	Substantially Equivalent	Sekisui Diagnostics P.E.I., Inc.
K160724	ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator	Sep 07, 2016	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K123977	RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR	Nov 21, 2013	Substantially Equivalent	Randox Laboratories, Ltd.
K112416	CPK REAGENT	Nov 09, 2011	Substantially Equivalent	Vital Diagnostics (Manufacturing) Ptyltd
K083465	DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE	Feb 27, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K081731	DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32	Aug 29, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics
K072548	CREATINE KINASE LIQUID REAGENT, MODEL C519-440	Apr 18, 2008	Substantially Equivalent	Teco Diagnostics
K062737	CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER	Jun 12, 2007	Substantially Equivalent	Horiba Abx
K051648	SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS	Jan 31, 2006	Substantially Equivalent	Arkray, Inc.
K043202	OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279	Dec 23, 2004	Substantially Equivalent	Olympus America, Inc.
K021332	WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA	Jul 03, 2002	Substantially Equivalent	Wiener Laboratories Saic
K013912	CREATINE KINASE (CK-NAC)	Jan 18, 2002	Substantially Equivalent	Jas Diagnostics, Inc.
K012474	ATAC PAK CPK REAGENT KIT	Oct 03, 2001	Substantially Equivalent	Elan Holdings, Inc.
K994189	OLYMPUS CREATINE KINASE REAGENT OSR6179/6279	Jan 20, 2000	Substantially Equivalent	Olympus Diagnostica GmbH
K992148	HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT	Dec 29, 1999	Substantially Equivalent	Morax
K983070	CK	Feb 16, 1999	Substantially Equivalent	Abbott Laboratories
K981218	CREATINE KINASE (CK)	May 01, 1998	Substantially Equivalent	Abbott Laboratories
K980900	N-ASSAY CPK-L	Mar 26, 1998	Substantially Equivalent	Crestat Diagnostics, Inc.
K973999	CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30	Mar 11, 1998	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K974833	CK-NAC REAGENT	Feb 13, 1998	Substantially Equivalent	Intersect Systems, Inc.
K972155	CREATINE KINASE (CK)	Jul 17, 1997	Substantially Equivalent	Stanbio Laboratory
K971566	CREATINE KINASE-MB REAGENT SET	Jul 14, 1997	Substantially Equivalent	Horizon Diagnostics, Inc.
K971396	CK REAGENT	May 29, 1997	Substantially Equivalent	Carolina Liquid Chemistries Corp.
K962247	HICHEM CK/NAC REAGENT KIT	Aug 15, 1996	Substantially Equivalent	Elan Pharma, Inc.
K951223	CK-MB (NAC-ACT)	Dec 26, 1995	Substantially Equivalent	Randox Laboratories, Ltd.
K952745	CREATINE KINASE REAGENT SYSTEM	Aug 11, 1995	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K952646	IL TEST CK-MB	Aug 04, 1995	Substantially Equivalent	Instrumentation Laboratory CO
K950177	CK QVET	Mar 03, 1995	Substantially Equivalent	Prisma Systems
K942773	CK-MB ASSAY, CATALOGUE NUMBER 317-10	Aug 24, 1994	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K935463	CREATINE KINASE-MB (CK-MB) REAGENT SET	Jan 11, 1994	Substantially Equivalent	Pointe Scientific, Inc.,
K933675	OPUS TOTAL CK	Sep 08, 1993	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K931889	CREATINE KINASE TEST	Jul 27, 1993	Substantially Equivalent	Em Diagnostic Systems, Inc.
K931326	KING DIAGNOSTICS CK REAGENT	Jun 15, 1993	Substantially Equivalent	King Diagnostics, Inc.
K930932	SYNERMED CREATINE KINASE REAGENT KIT	May 11, 1993	Substantially Equivalent	Synermed, Inc.
K930660	CREATINE KINASE (CK) REAGENT SET	Mar 29, 1993	Substantially Equivalent	Pointe Scientific, Inc.,
K924832	OLYMPUS CREATINE KINASE REAGENT	Jan 04, 1993	Substantially Equivalent	Olympus Corp.
K925801	REP E-Z CK-30 ISOENZYME KIT	Dec 28, 1992	Substantially Equivalent	Helena Laboratories
K923511	CK-NAC ACTIVATED KIT	Oct 15, 1992	Substantially Equivalent	Randox Laboratories, Ltd.
K924704	CREATINE KINASE (CK) TEST ITEM #65411	Oct 13, 1992	Substantially Equivalent	Em Diagnostic Systems, Inc.
K922459	OLYMPUS CREATINE KINASE REAGENT	Jul 13, 1992	Substantially Equivalent	Olympus Corp.
K915709	CREATINE KINASE-MB (CK-MB) REAGENT SET	Jan 27, 1992	Substantially Equivalent	Tech Intl. Co.
K914361	CREATINE KINASE MB TEST ITEM NUMBER 5A46	Dec 13, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K913398	RAICHEM(TM) CREATINE KINASE-MB REAGENT	Sep 25, 1991	Substantially Equivalent	Reagents Applications, Inc.
K905084	RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV	Dec 20, 1990	Substantially Equivalent	Reagents Applications, Inc.
K904004	AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116	Dec 11, 1990	Substantially Equivalent	Amresco, Inc.
K903775	CREATINE PHOSPHOKINASE	Oct 04, 1990	Substantially Equivalent	Amresco, Inc.
K904102	REFLOTRON CREATINE KINASE TEST TABS	Sep 27, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K903333	CREATINE KINASE TEST (CK) ITEM NUMBER 65411	Aug 17, 1990	Substantially Equivalent	Em Diagnostic Systems, Inc.
K902483	CREATINE KINASE-MB TEST (MB-DS) ITEM #67655	Jul 10, 1990	Substantially Equivalent	Em Diagnostic Systems, Inc.
K901267	COULTER CK (CREATINE KINASE) REAGENT	May 23, 1990	Substantially Equivalent	Coulter Corp.
K894715	CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS	Nov 08, 1989	Substantially Equivalent	Catachem, Inc.
K893691	EMDS CREATINE KINASE ITEM NIMBER 65411	Aug 31, 1989	Substantially Equivalent	Diagnostic Systems
K893269	BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME	Jul 20, 1989	Substantially Equivalent	Beckman Instruments, Inc.
K893007	REP(TM) CK-2 STAT KIT, CAT. NO. 3074	Jul 20, 1989	Substantially Equivalent	Helena Laboratories
K891462	ROCHE(R) CARDIOSCREEN-CK	May 22, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K891470	CK-NAC 2-VIAL REAGENT W/SUBSTRATE START	May 09, 1989	Substantially Equivalent	Trace Scientific , Ltd.
K890609	IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)	Mar 16, 1989	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K890540	ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC	Feb 27, 1989	Substantially Equivalent	Abbott Laboratories
K884547	CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673	Feb 10, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K884546	CREATINE KINASE TEST (CK) ITEM NUMBER: 65661	Feb 02, 1989	Substantially Equivalent	Em Diagnostic Systems, Inc.
K883946	VISION CREATINE KINASE	Oct 13, 1988	Substantially Equivalent	Abbott Laboratories
K883504	DURAZYME(R) CPK	Sep 13, 1988	Substantially Equivalent	American Monitor Corp.
K874146	TITAN GEL REP CPK-12 HV	Nov 05, 1987	Substantially Equivalent	Helena Laboratories
K873201	WAKO(TM) AUTOKIT CK-NAC	Nov 05, 1987	Substantially Equivalent	Wako Chemicals USA, Inc.
K874140	TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED.	Nov 03, 1987	Substantially Equivalent	Helena Laboratories
K874139	TITAN GEL REP CPK-30 HV	Nov 03, 1987	Substantially Equivalent	Helena Laboratories
K873134	UNIFAST CK-MB	Sep 16, 1987	Substantially Equivalent	Sclavo, Inc.
K870462	EASY-TEST CREATINE KINASE-MB (CK-MB) #16615	Mar 10, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K870461	EASY-TEST CREATINE KINASE (CK) NUMBER: 16614	Mar 06, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K864359	CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)	Feb 06, 1987	Substantially Equivalent	Trace Scientific , Ltd.
K864744	CREATINE PHOSPHOKINASE (CK)	Jan 13, 1987	Substantially Equivalent	Tech-Co, Inc.
K863587	CREATINE PHOSPHOKINASE(CK) PROCEDURE	Oct 03, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861665	CREATINE PHROSPHOKINASE (CK) PROCEDURE	Jun 05, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K861879	CK REAGENT CARTRIDGE (PRODUCT NO. 88213)	May 29, 1986	Substantially Equivalent	Hi Chem, Inc.
K861061	EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK	Apr 24, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K860733	CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE	Apr 24, 1986	Substantially Equivalent	Trace Scientific , Ltd.
K860669	CREATINE KINASE, N-ACETYL-L-CYSTIENE	Apr 07, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K860096	CPK REAGENT SET (COLORIMETRIC)	Feb 11, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K855056	EMDS TOTAL CK TEST PACK-#67670/95	Jan 22, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K854501	CK(OPTIMIZED) REAGENT	Dec 04, 1985	Substantially Equivalent	Sigma Diagnostics, Inc.
K852392	EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE	Oct 22, 1985	Substantially Equivalent	Helena Laboratories
K852483	SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205	Jul 12, 1985	Substantially Equivalent	Em Diagnostic Systems, Inc.
K852000	CK-NAC REAGENT	May 30, 1985	Substantially Equivalent	Alpkem Corp.
K850212	ISOENZYME TEST CK-MB	Feb 07, 1985	Substantially Equivalent	Sclavo, Inc.
K842755	TITAN GEL ISO DOT CPK PROCEDURE	Sep 28, 1984	Substantially Equivalent	Helena Laboratories
K843271	SYSTEMATE CK-TOTAL - 67206	Sep 07, 1984	Substantially Equivalent	Em Diagnostic Systems, Inc.
K842508	CREATINE KINASE ASSAY KIT NAC	Jul 20, 1984	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K842013	SIGMA PROCEDURE 47-UV	Jun 25, 1984	Substantially Equivalent	Sigma Chemical Co.
K840783	CREATINE KINASE MB REAGENT	Apr 04, 1984	Substantially Equivalent	American Dade
K834502	CK-NAC REAGENT	Feb 27, 1984	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K833781	DURAZYME CPK	Jan 18, 1984	Substantially Equivalent	American Monitor Corp.
K831965	CREATINE KINASE REAGENT CK LTS	Sep 12, 1983	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.
K831537	PARAMAX CREATINE KINASE REAGENT	Jun 22, 1983	Substantially Equivalent	American Dade
K821883	ULTRAZYME PLUS CK-I	Jul 14, 1982	Substantially Equivalent	Harleco Diagnostics
K821473	ULTRAZYME PLUS CKI, #64978,65027&65028	Jun 03, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K821464	CARDIOZYME PLUS CK-MB, #65045	Jun 02, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K821460	ULTRAZYME PLUS CK-I, #64978,65027&65028	Jun 01, 1982	Substantially Equivalent	Emd Chemicals, Inc.
K821240	LIQUID-STAT LIQUID ENZYME REAGENT	May 21, 1982	Substantially Equivalent	Beckman Instruments, Inc.
K820880	SERALYZER CK REAGENT STRIPS	Apr 16, 1982	Substantially Equivalent	Miles Laboratories, Inc.
K820644	RAICHEM TM CREATINE KINASE REAGENT	Apr 01, 1982	Substantially Equivalent	Reagents Applications, Inc.
K812593	ULTRA ZYME PLUS CK-1 #64978, 65027 & 28	Oct 02, 1981	Substantially Equivalent	Harleco
K811576	CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)	Jun 25, 1981	Substantially Equivalent	Harleco
K811574	CARDIOZYME PLUS CK-TOTAL ITEM #65046	Jun 25, 1981	Substantially Equivalent	Harleco
K810853	CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT	May 29, 1981	Substantially Equivalent	The Upjohn Co.
K803301	CREATINE KINASE REAGENT	Jan 16, 1981	Substantially Equivalent	Gilford Diagnostics
K801299	COBAS CK-NAC REAGENT	Jul 14, 1980	Substantially Equivalent	Roche Analytical Instruments, Inc.
K800127	CENTRIFICHEM CK	Feb 13, 1980	Substantially Equivalent	Union Carbide Corp.
K792477	CHEM-STRATE CK-NAC	Dec 27, 1979	Substantially Equivalent	General Diagnostics
K781859	REAGENT SYSTEM, NO 46-OV FOR CPK	Dec 04, 1978	Substantially Equivalent	Sigma Chemical Co.
K781719	CPK REAGENT SET, NAD REDUCTION	Nov 03, 1978	Substantially Equivalent	Medical Analysis Systems, Inc.
K781149	CPK-L TUBE	Aug 14, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K780311	DIAGNOSTIC KIT, CPK	Apr 05, 1978	Substantially Equivalent	Sclavo, Inc.
K780100	ULTRAZYME PLUS CK-1	Mar 09, 1978	Substantially Equivalent	Harleco
K780070	CPK REAGENT SET	Feb 13, 1978	Substantially Equivalent	Medical Analysis Systems, Inc.
K772352	STAC SYSTEM - ADDITIONAL ANALYTES	Jan 31, 1978	Substantially Equivalent	Technicon Instruments Corp.
K772258	CLINICARD CK-II	Jan 05, 1978	Substantially Equivalent	Harleco
K771849	CPK COLOR TEST KIT	Nov 03, 1977	Substantially Equivalent	Mallinckrodt Critical Care
K771389	CK-1 ULTRAZYME PLUS	Sep 02, 1977	Substantially Equivalent	Harleco
K771441	MULTISTAT III CPK TEST	Aug 22, 1977	Substantially Equivalent	Instrumentation Laboratory CO
K770694	CPK ULTRAZYME PLUS	Jul 01, 1977	Substantially Equivalent	Harleco Diagnostics
K770319	REAGENT CPK, ENZYME	Apr 05, 1977	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K761344	DYNAZYME-II TM CK-230 KIT	Jan 05, 1977	Substantially Equivalent	J.T. Baker Chemical Co.