(111 days)
The QUANTA Lite™ PBC Screen IgG/IgA ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies, gp210 antibodies, and sp100 antibodies of the IgG and/or IgA class in human serum. The presence of mitochondrial, gp210, and sp100 antibodies of the IgG and/or IgA class can be used in conjunction with other clinical and laboratory findings to aid in the diagnosis of primary biliary cirrhosis.
Not Found
I am sorry, but after carefully reviewing the provided document, I was unable to find the information necessary to answer your request regarding the acceptance criteria, study details, and specific performance metrics of the QUANTA Lite™ PBC Screen IgG/IgA ELISA device. The document is an FDA 510(k) clearance letter and an Indications for Use statement, which primarily confirm the device's substantial equivalence to a predicate device and its intended use. It does not contain the detailed study results or acceptance criteria you are looking for.
§ 866.5090 Antimitochondrial antibody immunological test system.
(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).