(54 days)
The Creatine kinase Reagent is to be used in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a Creatine Kinase Reagent. It states that the device has been found substantially equivalent to a predicate device for the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.
However, the document does not contain any information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, or training set details. These are typical requirements for device validation studies, but this specific FDA letter is a regulatory clearance document, not a detailed study report.
Therefore, I cannot provide the requested information from the given input.
§ 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.