(67 days)
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to glomerular basement membrane(GBM) in human serum. The results of the anti-GBM assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GBM antibodies including Goodpastures Syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. For in vitro diagnostic use only.
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to GBM in human serum. This device is designed for use with the Hycor Hy•Tec Automated EIA instrument.
This document is a 510(k) clearance letter from the FDA for two devices: Autostat™ Anti-GBM ELISA and HY•TEC Anti-GMB ELISA. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the devices are substantially equivalent to legally marketed predicate devices.
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§ 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).