(67 days)
An enzyme linked immunosorbant assay (ELISA) for the semi-quantitative detection of IgG autoantibodies to serine protease 3 (PR3). This test is to be used in conjunction with other clinical findings to aid in the assessment of certain autoimmune vasculitides such as Wegener's granulomatosis.
An enzyme linked immunosorbant assay (ELISA) for the semi-quantitative detection of IgG autoantibodies to serine protease 3 (PR3).
The provided text is a 510(k) clearance letter from the FDA for a device called "QUANTA Lite™ PR3 IgG". This letter approves the marketing of the device, but it does not contain the acceptance criteria or the study details proving the device meets those criteria.
The letter primarily states that the device is "substantially equivalent" to previously marketed devices and outlines regulatory information for the manufacturer. It specifies the "Indications For Use" which describe what the device is intended for, but not how well it performs.
Therefore, I cannot provide the requested information from this document. The document refers to a "510(k) premarket notification" which would contain the study data and acceptance criteria, but that is not included here.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).