(39 days)
The Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB, myoglobin and troponin I in human whole blood, serum, and plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.
Not Found
This is a notification letter from the FDA regarding the 510(k) submission for the Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test. It confirms that the device is substantially equivalent to a predicate device, allowing it to be marketed. However, the document provided is a regulatory approval letter and an indications for use statement. It does not contain the acceptance criteria, study details, or performance data for the device. Therefore, I cannot fulfill your request for that specific information based on the provided text.
The document states:
- Device Name: Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test
- Intended Use: For rapid qualitative determination of CK-MB, myoglobin, and troponin I in human whole blood, serum, and plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care, and hospital settings.
§ 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.