Product Code: JHW FDA class 2 21 CFR 862.1215

U.V. Method, Cpk Isoenzymes

Clinical Chemistry

UV Method for CPK Isoenzymes is a clinical chemistry test system employing ultraviolet spectrophotometric detection to measure creatine kinase isoenzyme activities in serum, used in cardiac and muscular disease diagnosis. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and compliance with general and special controls. The product code is JHW, 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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FEI Numbers

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Basic Information

Product Code: JHW
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 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K162526	Creatine Kinase-MB	May 26, 2017	Substantially Equivalent	Roche Diagnostics
K141265	ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT	Jul 18, 2014	Substantially Equivalent	Elitechgroup
K122083	ELITECH CLINICAL SYSTEMS CK NAC SL	Aug 22, 2012	Substantially Equivalent	Elitechgroup
K023744	WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354	Jan 03, 2003	Substantially Equivalent	Wiener Laboratories Saic
K003158	ROCHE DIAGNOSTICS CK-MB	Dec 18, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K961501	ELECSYS CK-MB	Jun 11, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K950186	CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM	Mar 13, 1995	Substantially Equivalent	Miles, Inc.
K944325	LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN	Feb 22, 1995	Substantially Equivalent	Princeton BioMeditech Corp.
K942958	CREATINE KINASE MB DETERMINATION (UV)	Nov 21, 1994	Substantially Equivalent	Biochemical Trade, Inc.
K935924	AXSYM CK-MB	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K931050	CARDIO REP CK ISOENZYME KIT - 3310	Apr 20, 1993	Substantially Equivalent	Helena Laboratories
K913349	STAMBI-CK	Oct 23, 1991	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K912231	PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT	Jul 08, 1991	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K905588	CREATINE KINASE UV REAGENT SET	Jan 17, 1991	Substantially Equivalent	Biochemical Trade, Inc.
K903508	LABELLING CHANGES TO IMPRES-MB-X	Sep 07, 1990	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K883222	ISOFOR-MM (TM)	Sep 30, 1988	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K881801	IMPRES-MB	Jun 08, 1988	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K822897	DSL 1700	Dec 15, 1982	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K811575	CARDIOZYME PLUS CK-MB ITEM #65045 (G)	Jun 25, 1981	Substantially Equivalent	Harleco
K811573	CARDIOZYME PLUS CK-MB ITEM #65045	Jun 25, 1981	Substantially Equivalent	Harleco
K810905	ISOMUNE-CK	Apr 14, 1981	Substantially Equivalent	Hoffmann-La Roche, Inc.
K810861	CREATINE KINASE MB ISOENZYME IMMUNO UV	Apr 14, 1981	Substantially Equivalent	The Dow Chemical Co.
K803168	CARDIO ZYME PLUS CK-MB #65045	Jan 09, 1981	Substantially Equivalent	Harleco
K792533	CREATINE PHOSPHOKINASE (CPK) REAGENT SET	Jan 11, 1980	Substantially Equivalent	Macomb Chemical Co.
K782015	A-GENT CK-MB	Feb 01, 1979	Substantially Equivalent	Abbott Laboratories
K781124	CPK ISOENZYME REAGENT	Aug 10, 1978	Substantially Equivalent	Electrophoresis Corp. of America
K772172	DYNAZYME TM II CARDIAK-MB	Dec 06, 1977	Substantially Equivalent	J.T. Baker Chemical Co.