(44 days)
Intended for the In Vitro, quantitative determination of aspartate amino transferase (AST) in human serum on automated chemistry analyzers.
Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
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This document is a 510(k) clearance letter for an in vitro diagnostic device, the AST (SGOT) REAGENT. It is a regulatory approval, not a scientific study report. Therefore, the provided text does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement in a performance study.
The document only states the "Indications for Use":
Device Name: AST (SGOT) REAGENT
Indications for Use: Intended for the In Vitro, quantitative determination of aspartate amino transferase (AST) in human serum on automated chemistry analyzers. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
To answer your request, a separate study report or a more detailed filing from JAS Diagnostics, Inc. to the FDA would be needed. This letter primarily confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
§ 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.