JHS · Differential Rate Kinetic Method, Cpk Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1215 · Class 2
Overview
| Product Code | JHS |
|---|---|
| Device Name | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Regulation | 21 CFR 862.1215 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Classification Rationale
Class II.
Cleared Devices (38)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K160570 | Creatine Kinase | Roche Diagnostics Operations (Rdo) | May 25, 2016 | SESE |
| K102706 | CKMB UDR ASSAY | SENTINEL CH. SpA | Aug 19, 2011 | SESE |
| K082226 | S40 CREATINE KINASE (CK) | Alfa Wassermann Diagnostic Technologies, Inc. | Sep 18, 2008 | SESE |
| K062128 | THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS | Dade Behring, Inc. | Aug 21, 2006 | SESE |
| K990439 | CARESIDE CK | Careside, Inc. | Apr 19, 1999 | SESE |
| K990434 | CARESIDE CKMB | Careside, Inc. | Apr 19, 1999 | SESE |
| K981495 | IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) | Diagnostic Products Corp. | Jun 10, 1998 | SESE |
| K962126 | ACS CKMB II IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Jun 21, 1996 | SESE |
| K952250 | STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT | Dade Intl., Inc. | Jul 17, 1995 | SESE |
| K945083 | ACCESS CK-MB REAGENTS | Bio-Rad Laboratories, Inc. | Nov 21, 1994 | SESE |
| K943024 | KINASE ISOENZYME | Dupont Medical Products | Aug 2, 1994 | SESE |
| K941584 | CREATINE KINASE METHOD | Dupont Medical Products | Jul 6, 1994 | SESE |
| K903025 | ROCHE ISOMUNE- CK | Roche Diagnostic Systems, Inc. | Aug 9, 1990 | SESE |
| K900806 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Healthcare Corp | Mar 23, 1990 | SESE |
| K883223 | CHECK-MM | Intl. Immunoassay Laboratories, Inc. | Sep 30, 1988 | SESE |
| K872029 | UNI-FAST CREATINE KINASE TEST (CK) | Sclavo, Inc. | Jun 17, 1987 | SESE |
| K861387 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) | Eastman Kodak Company | Jun 27, 1986 | SESE |
| K855188 | CPK (UV) REAGENT KIT | Technostics Intl. | Mar 5, 1986 | SESE |
| K854708 | DART CK-MB REAGENT SYSTEM | Coulter Electronics, Inc. | Dec 30, 1985 | SESE |
| K843007 | CARDI-CK EIA TEST KIT CK-MB ISOENZYME | Intl. Immunoassay Laboratories, Inc. | Sep 7, 1984 | SESE |
| K823211 | CK-UV REAGENT | Biorent Diagnostic, Inc. | Nov 22, 1982 | SESE |
| K820722 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE | Eastman Kodak Company | Apr 1, 1982 | SESE |
| K813406 | CPK(CK) IN VITRO DIAG. REAGENT SET | Pointe Scientific, Inc., | Dec 22, 1981 | SESE |
| K810997 | WORTHINGTON CK (NAC) REAGENT SET | Worthington Diagnostic Systems | Apr 23, 1981 | SESE |
| K803169 | CARDIOZYME PLUS CK-TOTAL #65046 | Harleco | Jan 9, 1981 | SESE |
| K802521 | CK-MB(IMMUNOLOGICAL) | Biodynamics Corp. | Nov 12, 1980 | SESE |
| K801668 | QUICK CEPT | Laboratory Diagnostics Co., Inc. | Aug 13, 1980 | SESE |
| K800028 | WORTHINGTON FLOZYME* CPK (340NM) | Worthington Diagnostic Systems | Jan 21, 1980 | SESE |
| K792023 | ESKACHEM, CK-MB REAGENT | Smithkline Diagnostics, Inc. | Oct 30, 1979 | SESE |
| K790918 | ESKLAB REAGENT TABLETS | Smithkline Diagnostics, Inc. | Jun 22, 1979 | SESE |
| K790917 | SPIN CHEM CK-NAC REAGENT | Smithkline Diagnostics, Inc. | Jun 22, 1979 | SESE |
| K790916 | CK-NUC REAGENT | Smithkline Diagnostics, Inc. | Jun 22, 1979 | SESE |
| K790343 | DATA-ZYME CK CALORIMETRIC/UV PROCEDURE | Data Medical Associates, Inc. | May 1, 1979 | SESE |
| K790088 | ACA CREATINE KINASE ISOENZYMES | E.I. Dupont DE Nemours & Co., Inc. | Mar 12, 1979 | SESE |
| K790015 | SERUM, CREATININE PHOSPHOKINASE | Fisher Scientific Co., LLC | Feb 15, 1979 | SESE |
| K781690 | L-CYSTEINE HYDROCHLORIDE | Fisher Scientific Co., LLC | Oct 27, 1978 | SESE |
| K781432 | STAT ULTRA VIOLET LIQUID | Beckman Instruments, Inc. | Oct 3, 1978 | SESE |
| K780504 | CREATINE PHOSPHOKINASE (CPK) | Gamma Enterprises, Inc. | May 3, 1978 | SESE |
Top Applicants
- Smithkline Diagnostics, Inc. — 4 clearances
- Worthington Diagnostic Systems — 2 clearances
- Intl. Immunoassay Laboratories, Inc. — 2 clearances
- Fisher Scientific Co., LLC — 2 clearances
- Eastman Kodak Company — 2 clearances
