(79 days)
Vital Diagnostics CPK Reagent is a device intended for the in vitro quantitative determination of creatine phosphokinase activity in human serum or plasma. 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.
Vital Diagnostics CPK Reagent
The provided text is a 510(k) clearance letter for a medical device called "Vital Diagnostics CPK Reagent". It primarily focuses on the regulatory approval of the device and its indications for use. The document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies.
Therefore, I cannot populate the requested information. The document is strictly a regulatory approval letter.
§ 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.