Product Code: JHY FDA class 2 21 CFR 862.1215

Colorimetric Method, Cpk Or Isoenzymes

Clinical Chemistry

Colorimetric Method for CPK or Isoenzymes is a clinical chemistry test system that employs colorimetric reactions to measure creatine kinase and its isoenzyme fractions in serum, supporting cardiac and muscular disease assessment. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JHY, regulated under 21 CFR 862.1215, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

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Basic Information

Product Code: JHY
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

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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
K143720	Dimension Vista MMB Assay	Sep 18, 2015	Substantially Equivalent	Siemens Healthcare Diagnostics
K130080	EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL	May 13, 2014	Substantially Equivalent	Medica Corporation
K140404	ELECSYS CK-MB STAT IMMUNOASSAY	May 08, 2014	Substantially Equivalent	Roche Diagnostics
K132571	ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY	Oct 18, 2013	Substantially Equivalent	Roche Diagnostics
K070835	OLYMPUS CK-MB REAGENT	Jun 04, 2007	Substantially Equivalent	Olympus Life & Material Science Europa GmbH (Irish
K022757	SPIFE CK KIT, MODEL 3332, 3333	Oct 11, 2002	Substantially Equivalent	Helena Laboratories
K022654	MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB	Aug 29, 2002	Substantially Equivalent	Roche Diagnostics Corp.
K974421	ELECSYS CK-MB STAT	Dec 17, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K970343	MMB METHOD	Feb 14, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K961412	CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO	Jun 18, 1996	Substantially Equivalent	Bayer Corp.
K951638	AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK	May 02, 1995	Substantially Equivalent	Organon Teknika Corp.
K931172	IMX(R) STAT CK-MB	Jun 15, 1993	Substantially Equivalent	Abbott Laboratories
K924429	OPUS(R) CK-MB	Oct 15, 1992	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K922700	DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.	Aug 20, 1992	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K921763	TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY	Jun 09, 1992	Substantially Equivalent	Hybritech, Inc.
K912766	AMERLITE CK-MB ASSAY	Jul 17, 1991	Substantially Equivalent	Amersham Corp.
K896240	COBAS READY CK REAGENT	Feb 16, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K895870	ISOSCREEN-CK CONFIRMATORY KIT	Dec 01, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K890295	TARGET(TM) CK-MB	Aug 15, 1989	Substantially Equivalent	V-Tech, Inc.
K884550	CREATINE KINASE MB ENZYME IMMUNOASSAY KIT	Feb 23, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K884085	TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY	Dec 02, 1988	Substantially Equivalent	Hybritech, Inc.
K883013	IMX CKMB	Aug 08, 1988	Substantially Equivalent	Abbott Laboratories
K881351	IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225	Jun 01, 1988	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K875192	KODAK EKTACHEM DT SLIDES (CKMB)	Feb 24, 1988	Substantially Equivalent	Eastman Kodak Company
K880178	CREATINE KINASE (COLORIMETRIC METHOD)	Feb 18, 1988	Substantially Equivalent	Tech-Co, Inc.
K874545	IMACK-MB TEST PROCEDURE (MODIFICATION)	Dec 18, 1987	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K872063	TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II	Jun 19, 1987	Substantially Equivalent	Hybritech, Inc.
K871677	CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS	May 12, 1987	Substantially Equivalent	Catachem, Inc.
K860663	AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT	Apr 11, 1986	Substantially Equivalent	Amresco, Inc.
K845024	BAKER CKMB REAGENT SET	Jan 18, 1985	Substantially Equivalent	Hybritech, Inc.
K832977	FLOW-PAC CPK REAGENT SET	Apr 05, 1984	Substantially Equivalent	American Research Products Co.
K832139	TANDEM - E-CKMB IMMUNOENZYMETRIC ASSAY	Aug 12, 1983	Substantially Equivalent	Hybritech, Inc.
K832004	WAKO CPK TEST	Aug 11, 1983	Substantially Equivalent	Wako Chemicals USA, Inc.
K830672	CREATINE KINASE REAGENT SET	Apr 05, 1983	Substantially Equivalent	Sterling Biochemical, Inc.
K820812	CREATINE KINASE-MB KIT	Apr 12, 1982	Substantially Equivalent	Calbiochem-Behring Corp.
K800684	REAGENT FOR DETERM. CREATINE PHOSPHOKINA	May 28, 1980	Substantially Equivalent	Diagnostic Solutions, Inc.
K791655	CPK ISOENZYME REAGENT	Sep 17, 1979	Substantially Equivalent	Electrophoresis Corp. of America
K790309	CPK ISOENZYME SUBSTRATE	Apr 04, 1979	Substantially Equivalent	Electrophoresis Corp.
K761212	CPK1SOENZYMES DETERMINATION PRO. #715-EP	Dec 21, 1976	Substantially Equivalent	Sigma Chemical Co.
K760871	LANCER MB/CPK ISOENZYME KIT	Nov 02, 1976	Substantially Equivalent	Sherwood Medical Industries