(67 days)
A semiquantitative enzyme linked immunosorbant assay (ELISA) detecting IgG class autoantibody to glomerular basement membrane (GBM) in human serum. This test is an aid in the diagnosis of autoimmune renal disorders such as Goodpasture's syndrome.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called QUANTA Lite™ GBM ELISA. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the acceptance criteria or the details of a study proving the device meets those criteria, nor does it provide information about the development and testing of a new AI/ML device.
The letter is a regulatory approval, and while it references a 510(k) submission (K984336), the submission itself, which would contain the study details, is not provided in the input text. Therefore, I cannot extract the requested information.
§ 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).