(459 days)
PATHFAST CK-MB-II test is an in vitro diagnostic test for the quantitative measurement of creatine kinase-MB in heparinized or EDTA whole blood and plasma. Measurements of CK-MB are used in the aid of diagnosis of acute myocardial infarction. This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.
PATHFAST Myo-II test is an in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized or EDTA whole blood and plasma. Measurements of myoglobin are used to assist in the aid of diagnosis of myocardial infarction (MI). This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.
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The provided text is a 510(k) premarket notification letter from the FDA to Mitsubishi Kagaku Iatron Inc. regarding their PATHFAST CK-MB-II and PATHFAST Myo-II diagnostic tests. It primarily addresses the regulatory approval of these devices and their intended use. It does not include information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or performance evaluation section.
Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval and indications for use, not on the detailed technical performance data or study methodology.
§ 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.