(156 days)
The VBL Serum Troponin I ELISA Test is intended for the quantitative determination of cardiac Troponin I in human serum. Measurement of Troponin I values are useful in the evaluation of acute myocardial infarction (AMI).
Not Found
The provided text is a 510(k) clearance letter from the FDA for a diagnostic test kit for cardiac Troponin I. It does not contain the acceptance criteria or a study describing the device's performance against those criteria.
Therefore, I cannot extract the requested information as it is not present in the provided document. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed subject to general controls.
§ 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.