(83 days)
The In Vitro Nano-Check ™ AMI cTnI Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnl) in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI).
The In Vitro Nano-Check ™ AMI cTnl Test is a qualitative assay, which cannot monitor the rise and fall of cTnl in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other test results and patient clinical findings.
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The provided text is a 510(k) premarket notification approval letter for the "In Vitro Nano-Check™ AMI cTnI Cardiac Marker Test". It confirms that the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, expert qualifications, ground truth establishment, or any other specifics related to a device performance study.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study details based on the provided input. The document is an FDA approval letter, not a 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.