(167 days)
The Creatine Kinase assay is used for the quantitation of creatine kinase in human serum or plasma on the AEROSET™ instrument. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Creatine Kinase is an in vitro diagnostic assay for the quantitative determination of creatine kinase in human serum or plasma. The Creatine Kinase assay is a clinical chemistry assay in which the creatine kinase present in the sample catalyzes the transfer of a high energy phosphate group from creatine phosphate to ADP. The ATP produced in this reaction is subsequently used to phosphorylate glucose to produce glucose-6-phosphate (G-6-P) in the presence of hexokinase. G-6-P is then oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the concomitant reduction of NADP to NADPH. The rate of formation of NADPH is monitored at 340 nm and is proportional to the activity of creatine kinase in the sample.
Here's an analysis of the provided information regarding the Creatine Kinase assay, focusing on its acceptance criteria and the study that proves it meets those criteria:
Acceptance Criteria and Device Performance for Creatine Kinase Assay
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Method Comparison (vs. Predicate) | Correlation Coefficient | High correlation (e.g., >0.95) | 0.999 |
| Slope | Close to 1 (e.g., 0.95 - 1.05) | 0.988 | |
| Y-intercept | Close to 0 | -0.829 U/L | |
| Precision | Total %CV (Level 1) | Low (e.g., |
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
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.(b)
Classification. Class II.