(23 days)
For the quantitative determination of aspartate aminotransferase in serum. For IN VITRO diagnostic use.
Elevated levels of aspartate aminotransferase result from a myocardial infarction, or hepatic disease. In cases of hepatic necrosis, elevations of AST levels occur prior to the onset of clinical symptoms such as jaundice. To a lesser extent elevated levels are indicative of diseases of some internal organs.
Aspartate Aminotransferase-SL Assay
The provided text is a 510(k) clearance letter from the FDA for the Aspartate Aminotransferase-SL Assay. While it confirms the device's substantial equivalence to a predicate device and its indications for use, it does not contain the detailed study information needed to answer the questions about acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information from the given text. The letter primarily addresses regulatory approval and does not delve into the specifics of the performance study that would have underpinned the submission.
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.