NJV · Test, Albumin Cobalt Binding
Clinical Chemistry · 21 CFR 862.1215 · Class 2
Overview
| Product Code | NJV |
|---|---|
| Device Name | Test, Albumin Cobalt Binding |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053196 | ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) | Inverness Medical Innovations, Inc. | Dec 16, 2005 | SESE |
| K023824 | ALBUMIN COBALT BINDING TEST (ACB TEST) | Ischemia Technologies, Inc. | Feb 14, 2003 | SESU |
Top Applicants
- Inverness Medical Innovations, Inc. — 1 clearance
- Ischemia Technologies, Inc. — 1 clearance
