JHY · Colorimetric Method, Cpk Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1215 · Class 2
Overview
| Product Code | JHY |
|---|---|
| Device Name | Colorimetric 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 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K143720 | Dimension Vista MMB Assay | Siemens Healthcare Diagnostics | Sep 18, 2015 | SESE |
| K130080 | EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL | Medica Corporation | May 13, 2014 | SESE |
| K140404 | ELECSYS CK-MB STAT IMMUNOASSAY | Roche Diagnostics | May 8, 2014 | SESE |
| K132571 | ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY | Roche Diagnostics | Oct 18, 2013 | SESE |
| K070835 | OLYMPUS CK-MB REAGENT | Olympus Life & Material Science Europa GmbH (Irish | Jun 4, 2007 | SESE |
| K022757 | SPIFE CK KIT, MODEL 3332, 3333 | Helena Laboratories | Oct 11, 2002 | SESE |
| K022654 | MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB | Roche Diagnostics Corp. | Aug 29, 2002 | SESE |
| K974421 | ELECSYS CK-MB STAT | Boehringer Mannheim Corp. | Dec 17, 1997 | SESE |
| K970343 | MMB METHOD | Dade Chemistry Systems, Inc. | Feb 14, 1997 | SESE |
| K961412 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO | Bayer Corp. | Jun 18, 1996 | SESE |
| K951638 | AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK | Organon Teknika Corp. | May 2, 1995 | SESE |
| K931172 | IMX(R) STAT CK-MB | Abbott Laboratories | Jun 15, 1993 | SESE |
| K924429 | OPUS(R) CK-MB | Pb Diagnostic Systems, Inc. | Oct 15, 1992 | SESE |
| K922700 | DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. | E.I. Dupont DE Nemours & Co., Inc. | Aug 20, 1992 | SESE |
| K921763 | TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | Jun 9, 1992 | SESE |
| K912766 | AMERLITE CK-MB ASSAY | Amersham Corp. | Jul 17, 1991 | SESE |
| K896240 | COBAS READY CK REAGENT | Roche Diagnostic Systems, Inc. | Feb 16, 1990 | SESE |
| K895870 | ISOSCREEN-CK CONFIRMATORY KIT | Roche Diagnostic Systems, Inc. | Dec 1, 1989 | SESE |
| K890295 | TARGET(TM) CK-MB | V-Tech, Inc. | Aug 15, 1989 | SESE |
| K884550 | CREATINE KINASE MB ENZYME IMMUNOASSAY KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 23, 1989 | SESE |
Top Applicants
- Hybritech, Inc. — 5 clearances
- Roche Diagnostics — 2 clearances
- Roche Diagnostic Systems, Inc. — 2 clearances
- Intl. Immunoassay Laboratories, Inc. — 2 clearances
- Abbott Laboratories — 2 clearances
