JHW · U.V. Method, Cpk Isoenzymes
Clinical Chemistry · 21 CFR 862.1215 · Class 2
Overview
| Product Code | JHW |
|---|---|
| Device Name | U.V. Method, 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 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162526 | Creatine Kinase-MB | Roche Diagnostics | May 26, 2017 | SESE |
| K141265 | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT | Elitechgroup | Jul 18, 2014 | SESE |
| K122083 | ELITECH CLINICAL SYSTEMS CK NAC SL | Elitechgroup | Aug 22, 2012 | SESE |
| K023744 | WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354 | Wiener Laboratories Saic | Jan 3, 2003 | SESE |
| K003158 | ROCHE DIAGNOSTICS CK-MB | Roche Diagnostics Corp. | Dec 18, 2000 | SESE |
| K961501 | ELECSYS CK-MB | Boehringer Mannheim Corp. | Jun 11, 1996 | SESE |
| K950186 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | Miles, Inc. | Mar 13, 1995 | SESE |
| K944325 | LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN | Princeton BioMeditech Corp. | Feb 22, 1995 | SESE |
| K942958 | CREATINE KINASE MB DETERMINATION (UV) | Biochemical Trade, Inc. | Nov 21, 1994 | SESE |
| K935924 | AXSYM CK-MB | Abbott Laboratories | Jun 21, 1994 | SESE |
| K931050 | CARDIO REP CK ISOENZYME KIT - 3310 | Helena Laboratories | Apr 20, 1993 | SESE |
| K913349 | STAMBI-CK | Intl. Immunoassay Laboratories, Inc. | Oct 23, 1991 | SESE |
| K912231 | PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT | Intl. Immunoassay Laboratories, Inc. | Jul 8, 1991 | SESE |
| K905588 | CREATINE KINASE UV REAGENT SET | Biochemical Trade, Inc. | Jan 17, 1991 | SESE |
| K903508 | LABELLING CHANGES TO IMPRES-MB-X | Intl. Immunoassay Laboratories, Inc. | Sep 7, 1990 | SESE |
| K883222 | ISOFOR-MM (TM) | Intl. Immunoassay Laboratories, Inc. | Sep 30, 1988 | SESE |
| K881801 | IMPRES-MB | Intl. Immunoassay Laboratories, Inc. | Jun 8, 1988 | SESE |
| K822897 | DSL 1700 | Diagnostic Systems Laboratories, Inc. | Dec 15, 1982 | SESE |
| K811575 | CARDIOZYME PLUS CK-MB ITEM #65045 (G) | Harleco | Jun 25, 1981 | SESE |
| K811573 | CARDIOZYME PLUS CK-MB ITEM #65045 | Harleco | Jun 25, 1981 | SESE |
Top Applicants
- Intl. Immunoassay Laboratories, Inc. — 5 clearances
- Harleco — 3 clearances
- Abbott Laboratories — 2 clearances
- Biochemical Trade, Inc. — 2 clearances
- Elitechgroup — 2 clearances
