(52 days)
The SPIFE CK Kit is used in the identification and quantitation of serum creatine kinase isoenzymes. This test is especially useful in detecting acute myocardial infarction (AMI) when used in conjunction with LD isoenzyme studies.
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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.
The document is a 510(k) clearance letter from the FDA for the "SPIFE CK Kit". It states that the device is substantially equivalent to a legally marketed predicate device for the identification and quantitation of serum creatine kinase isoenzymes, particularly useful in detecting acute myocardial infarction. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Information on experts, adjudication methods, or ground truth establishment for a test set.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes.
- Information about a standalone algorithm performance study.
- Details on the type of ground truth used.
- Sample size for a training set or how its ground truth was established.
This document is a regulatory approval, not a scientific study report.
§ 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.