Product Code: JHS FDA class 2 21 CFR 862.1215

Differential Rate Kinetic Method, Cpk Or Isoenzymes

Clinical Chemistry

Differential Rate Kinetic Method for CPK or Isoenzymes is a clinical chemistry test system that measures the activity and isoenzyme fractions of creatine phosphokinase (CPK/CK) using kinetic differentiation techniques, used in the diagnosis of myocardial infarction, myopathies, and rhabdomyolysis. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is JHS, 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: JHS
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 38 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K160570	Creatine Kinase	May 25, 2016	Substantially Equivalent	Roche Diagnostics Operations (Rdo)
K102706	CKMB UDR ASSAY	Aug 19, 2011	Substantially Equivalent	SENTINEL CH. SpA
K082226	S40 CREATINE KINASE (CK)	Sep 18, 2008	Substantially Equivalent	Alfa Wassermann Diagnostic Technologies, Inc.
K062128	THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS	Aug 21, 2006	Substantially Equivalent	Dade Behring, Inc.
K990439	CARESIDE CK	Apr 19, 1999	Substantially Equivalent	Careside, Inc.
K990434	CARESIDE CKMB	Apr 19, 1999	Substantially Equivalent	Careside, Inc.
K981495	IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)	Jun 10, 1998	Substantially Equivalent	Diagnostic Products Corp.
K962126	ACS CKMB II IMMUNOASSAY	Jun 21, 1996	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K952250	STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT	Jul 17, 1995	Substantially Equivalent	Dade Intl., Inc.
K945083	ACCESS CK-MB REAGENTS	Nov 21, 1994	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K943024	KINASE ISOENZYME	Aug 02, 1994	Substantially Equivalent	Dupont Medical Products
K941584	CREATINE KINASE METHOD	Jul 06, 1994	Substantially Equivalent	Dupont Medical Products
K903025	ROCHE ISOMUNE- CK	Aug 09, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K900806	STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY	Mar 23, 1990	Substantially Equivalent	Baxter Healthcare Corp
K883223	CHECK-MM	Sep 30, 1988	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K872029	UNI-FAST CREATINE KINASE TEST (CK)	Jun 17, 1987	Substantially Equivalent	Sclavo, Inc.
K861387	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)	Jun 27, 1986	Substantially Equivalent	Eastman Kodak Company
K855188	CPK (UV) REAGENT KIT	Mar 05, 1986	Substantially Equivalent	Technostics Intl.
K854708	DART CK-MB REAGENT SYSTEM	Dec 30, 1985	Substantially Equivalent	Coulter Electronics, Inc.
K843007	CARDI-CK EIA TEST KIT CK-MB ISOENZYME	Sep 07, 1984	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K823211	CK-UV REAGENT	Nov 22, 1982	Substantially Equivalent	Biorent Diagnostic, Inc.
K820722	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE	Apr 01, 1982	Substantially Equivalent	Eastman Kodak Company
K813406	CPK(CK) IN VITRO DIAG. REAGENT SET	Dec 22, 1981	Substantially Equivalent	Pointe Scientific, Inc.,
K810997	WORTHINGTON CK (NAC) REAGENT SET	Apr 23, 1981	Substantially Equivalent	Worthington Diagnostic Systems
K803169	CARDIOZYME PLUS CK-TOTAL #65046	Jan 09, 1981	Substantially Equivalent	Harleco
K802521	CK-MB(IMMUNOLOGICAL)	Nov 12, 1980	Substantially Equivalent	Biodynamics Corp.
K801668	QUICK CEPT	Aug 13, 1980	Substantially Equivalent	Laboratory Diagnostics Co., Inc.
K800028	WORTHINGTON FLOZYME* CPK (340NM)	Jan 21, 1980	Substantially Equivalent	Worthington Diagnostic Systems
K792023	ESKACHEM, CK-MB REAGENT	Oct 30, 1979	Substantially Equivalent	Smithkline Diagnostics, Inc.
K790918	ESKLAB REAGENT TABLETS	Jun 22, 1979	Substantially Equivalent	Smithkline Diagnostics, Inc.
K790917	SPIN CHEM CK-NAC REAGENT	Jun 22, 1979	Substantially Equivalent	Smithkline Diagnostics, Inc.
K790916	CK-NUC REAGENT	Jun 22, 1979	Substantially Equivalent	Smithkline Diagnostics, Inc.
K790343	DATA-ZYME CK CALORIMETRIC/UV PROCEDURE	May 01, 1979	Substantially Equivalent	Data Medical Associates, Inc.
K790088	ACA CREATINE KINASE ISOENZYMES	Mar 12, 1979	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K790015	SERUM, CREATININE PHOSPHOKINASE	Feb 15, 1979	Substantially Equivalent	Fisher Scientific Co., LLC
K781690	L-CYSTEINE HYDROCHLORIDE	Oct 27, 1978	Substantially Equivalent	Fisher Scientific Co., LLC
K781432	STAT ULTRA VIOLET LIQUID	Oct 03, 1978	Substantially Equivalent	Beckman Instruments, Inc.
K780504	CREATINE PHOSPHOKINASE (CPK)	May 03, 1978	Substantially Equivalent	Gamma Enterprises, Inc.