(50 days)
The Spectral's Troponin I test is intended for use as an in vitro diagnostic product for the rapid quantitative determination of cardiac troponin I in human whole blood, serum, and plasma. The test is used as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.
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The provided text is a 510(k) clearance letter from the FDA for "Spectral's Troponin I Test," an in vitro diagnostic device. This document does not contain the detailed information required to answer your prompt regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment for an AI/device performance study.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and directs the manufacturer to various FDA offices for further information on labeling, promotion, and other responsibilities.
Therefore, I cannot extract the requested information from the provided text. The document does not describe a study that proves the device meets acceptance criteria in the way you've outlined for an AI/device performance evaluation.
§ 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.