(113 days)
AIA-PACK cTnl 2nd-Gen is designated for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of cardiac troponin I (cTnl) in human heparinized plasma on specific TOSOH AIA System analyzers. Cardiac troponin I measurements are used as an aid in the diagnosis of acute myocardial infarction (AMI).
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This document is a 510(k) premarket notification decision letter from the FDA for an in-vitro diagnostic device, the AIA-PACK® cTNI 2nd Gen Troponin I Assay. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as requested in your prompt. This type of information is typically found in the 510(k) summary or the full submission, which is not included here. The letter only confirms the FDA's decision to allow the device to be marketed.
Therefore, I cannot fulfill your request for the specific details of acceptance criteria and study design based solely on the provided FDA 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.