21 CFR 862.1215 — Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1215
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 | 123 | 3rd Party |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 2 | 38 | 3rd Party |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 2 | 21 | 3rd Party |
| JHW | U.V. Method, Cpk Isoenzymes | 2 | 27 | 3rd Party |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 2 | 48 | 3rd Party |
| JHY | Colorimetric Method, Cpk Or Isoenzymes | 2 | 40 | 3rd Party |
| MMI | Immunoassay Method, Troponin Subunit | 2 | 94 | |
| MYT | Biosensor, Immunoassay, Cpk Or Isoenzymes | 2 | 3 | 3rd Party |
| NJV | Test, Albumin Cobalt Binding | 2 | 2 | 3rd Party |
