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.
Recent Cleared Devices (20 of 38)
Showing 20 most recent of 38 cleared devices.
| 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 |
Top Applicants
- Smithkline Diagnostics, Inc. — 4 clearances
- Careside, Inc. — 2 clearances
- Dupont Medical Products — 2 clearances
- Eastman Kodak Company — 2 clearances
- Fisher Scientific Co., LLC — 2 clearances
