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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.

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