CGS · Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1215 · Class 2
Overview
| Product Code | CGS |
|---|---|
| Device Name | Nad Reduction/Nadh Oxidation, 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 123)
Showing 20 most recent of 123 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191296 | Pointe Scientific Creatinine Kinase (CK) Reagent Set | Medtest DX | Aug 11, 2020 | SESE |
| K182702 | SEKURE Creatine Kinase Assay | Sekisui Diagnostics P.E.I., Inc. | Apr 17, 2019 | SESE |
| K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator | Siemens Healthcare Diagnostics, Inc. | Sep 7, 2016 | SESE |
| K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | Randox Laboratories, Ltd. | Nov 21, 2013 | SESE |
| K112416 | CPK REAGENT | Vital Diagnostics (Manufacturing) Ptyltd | Nov 9, 2011 | SESE |
| K083465 | DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | Feb 27, 2009 | SESE |
| K081731 | DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 | Siemens Healthcare Diagnostics | Aug 29, 2008 | SESE |
| K072548 | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 | Teco Diagnostics | Apr 18, 2008 | SESE |
| K062737 | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Horiba Abx | Jun 12, 2007 | SESE |
| K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | Arkray, Inc. | Jan 31, 2006 | SESE |
| K043202 | OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 | Olympus America, Inc. | Dec 23, 2004 | SESE |
| K021332 | WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA | Wiener Laboratories Saic | Jul 3, 2002 | SESE |
| K013912 | CREATINE KINASE (CK-NAC) | Jas Diagnostics, Inc. | Jan 18, 2002 | SESE |
| K012474 | ATAC PAK CPK REAGENT KIT | Elan Holdings, Inc. | Oct 3, 2001 | SESE |
| K994189 | OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 | Olympus Diagnostica GmbH | Jan 20, 2000 | SESE |
| K992148 | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT | Morax | Dec 29, 1999 | SESE |
| K983070 | CK | Abbott Laboratories | Feb 16, 1999 | SESE |
| K981218 | CREATINE KINASE (CK) | Abbott Laboratories | May 1, 1998 | SESE |
| K980900 | N-ASSAY CPK-L | Crestat Diagnostics, Inc. | Mar 26, 1998 | SESE |
| K973999 | CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 | Diagnostic Chemicals , Ltd. | Mar 11, 1998 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 14 clearances
- Helena Laboratories — 7 clearances
- Harleco — 6 clearances
- Abbott Laboratories — 4 clearances
- Emd Chemicals, Inc. — 3 clearances
