(107 days)
In-vitro measurement of IgG anticardiolipin antibodies in human serum, as an aid in the diagnosis of anticardiolipin syndrome.
Not Found
The provided text is a letter from the FDA regarding the clearance of a medical device, the "Anticardiolipin IgG Screen EIA Kit." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily addresses the device's substantial equivalence to a predicate device and its regulatory classification.
Therefore, I cannot extract the requested information as it is not present in the provided document.
§ 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).