(76 days)
For in vitro diagnostic use in the quantitative determination of creatine kinase-MB in recommended when Acute Myocardial Infarction is suspected.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA for a Creatine Kinase-MB Reagent Set. This document is a regulatory clearance for an in vitro diagnostic device and does not contain the detailed study information typically found in clinical trials for AI/ML-based medical devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and device performance based on the input document. The document primarily focuses on regulatory approval, substantial equivalence to a predicate device, and general regulatory requirements for marketing the device.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Details about experts for ground truth establishment or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample sizes for training sets or how their ground truth was established.
This is a clearance letter for a chemical reagent set, not an AI/ML-driven device, so the type of performance data requested is not applicable to this document.
§ 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.