(49 days)
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative kinetic determination of gamma glutamyl transferase in serum. It is intended for in vitro diagnostic use only. The determination of gamma glutamyl transferase in serum is most commonly performed for the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and secondary liver tumors.
Liquid GGT (Gamma Glutamyl Transferase) Reagent Set
This document is an FDA 510(k) clearance letter for a "Liquid GGT (Gamma Glutamyl Transferase) Reagent Set." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain the information requested regarding acceptance criteria and study details for device performance.
The letter focuses on regulatory approval, classification, and general controls, rather than a detailed technical performance study report.
Therefore, I cannot provide the requested information from the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed device performance validation report.
§ 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
(a)
Identification. A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.(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.