JHT · Chromatographic Separation, Cpk Isoenzymes
Clinical Chemistry · 21 CFR 862.1215 · Class 2
Overview
| Product Code | JHT |
|---|---|
| Device Name | Chromatographic Separation, Cpk 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 21)
Showing 20 most recent of 21 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022409 | SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST | Spectral Diagnostics, Inc. | Sep 30, 2002 | SESE |
| K991299 | MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI | Princeton BioMeditech Corp. | May 28, 1999 | SESE |
| K930359 | CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 | Helena Laboratories | Apr 12, 1993 | SESE |
| K904866 | COULTER CK-MB ISOENZYME REAGENT | Coulter Electronics, Inc. | Dec 13, 1990 | SESE |
| K904721 | DSL CK-MB (DSL #3200) | Diagnostic Systems Laboratories, Inc. | Dec 13, 1990 | SESE |
| K901450 | MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB | Intl. Immunoassay Laboratories, Inc. | May 15, 1990 | SESE |
| K896170 | REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 | Helena Laboratories | Feb 16, 1990 | SESE |
| K881168 | CREATINE KINASE (CK) ISOENZYME MB | Data Medical Associates, Inc. | Nov 10, 1988 | SESE |
| K874284 | SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM | Diagnostic Chemicals, Ltd. (Usa) | Jan 21, 1988 | SESE |
| K872041 | COULTER DART CK-MB ISOENZYME REAGENT SYSTEM | Coulter Electronics, Inc. | Sep 16, 1987 | SESE |
| K872598 | MICROMI-CK(TM) | Intl. Immunoassay Laboratories, Inc. | Aug 3, 1987 | SESE |
| K872592 | IMACK-MB(TM) | Intl. Immunoassay Laboratories, Inc. | Jul 31, 1987 | SESE |
| K831391 | SHOT GUN KIT FOR CK-MB | Serapine Corp. | Nov 4, 1983 | SESE |
| K823550 | CK-ISOZYME U.V. REAGENT SET | Gelman Sciences, Inc. | Jan 7, 1983 | SESE |
| K822124 | TITAN GEL CPK ISOENZYME SYSTEM | Helena Laboratories | Nov 1, 1982 | SESE |
| K821964 | 125I QUICK-MB TEST KIT FOR QUANTITATION | Intl. Immunoassay Laboratories, Inc. | Jul 22, 1982 | SESE |
| K810534 | GEMENI QUICK-MB SEPARATION KIT | Gemini, Inc. | Mar 11, 1981 | SESE |
| K791826 | CPK CLINI GEL KIT | Clinical Sciences, Inc. | Oct 1, 1979 | SESE |
| K790357 | CPK-CS | Hoffmann-La Roche, Inc. | Apr 4, 1979 | SESE |
| K771497 | CK-MB | Boehringer Mannheim Corp. | Aug 22, 1977 | SESE |
Top Applicants
- Intl. Immunoassay Laboratories, Inc. — 4 clearances
- Helena Laboratories — 3 clearances
- Coulter Electronics, Inc. — 2 clearances
- Boehringer Mannheim Corp. — 1 clearance
- Clinical Sciences, Inc. — 1 clearance
