MYT · Biosensor, Immunoassay, Cpk Or Isoenzymes
Clinical Chemistry · 21 CFR 862.1215 · Class 2
Overview
| Product Code | MYT |
|---|---|
| Device Name | Biosensor, Immunoassay, 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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K051433 | I-STAT CREATINE KINASE MB (CK-MB) | I-Stat Corporation | Dec 15, 2005 | SESE |
| K033155 | BIOCENTREX CARDIAC PANEL | Biocentrex | Jan 12, 2004 | SESE |
| K984433 | QUANTECH CK-MB ASSAY | Quantech , Ltd. | Nov 1, 1999 | SESE |
Top Applicants
- Quantech , Ltd. — 1 clearance
- I-Stat Corporation — 1 clearance
- Biocentrex — 1 clearance
