Search Results

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.

Ask a specific question about this device