(71 days)
For the qualitative determination of CK-MB, myoglobin, and cardiac troponin I in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, pointof-care, and hospital settings.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Spectral Cardiac STATus™ CK-MB-Myoglobin/Troponin I 3-in-1 test." This document is an approval letter and an "Indications for Use" statement, not a study report or clinical trial summary.
Therefore, it does not contain the acceptance criteria or the study details requested in your prompt. It only states that the device is substantially equivalent to legally marketed predicate devices and outlines its intended use.
To answer your questions, I would need access to the actual 510(k) submission document or a clinical study report for this device, which are not provided in the input text.
§ 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.