(45 days)
For the quantitative determination of alanine aminotransferase in serum. For IN VITRO diagnostic use. Elevated levels of alanine aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of ALT levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent levels are indicative of diseases of some internal organs.
Alanine Aminotransferase-SL Assay
This appears to be a 510(k) clearance letter from the FDA for an Alanine Aminotransferase-SL Assay. The document does not describe the acceptance criteria or the specifics of a study conducted to prove the device meets those criteria. Such information is typically found in the 510(k) submission itself, not in the clearance letter.
Therefore, I cannot provide the requested information based on the provided text. The document is essentially an approval letter stating that the device is substantially equivalent to a predicate device. It does not contain the detailed study results or acceptance criteria.
§ 862.1030 Alanine amino transferase (ALT/SGPT) test system.
(a)
Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.