(98 days)
The EUROIMMUN Anti-BP180-4X ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against BP180 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid (PB), in conjunction with other laboratory and clinical findings.
Not Found
This is a 510(k) premarket notification decision letter, not a study report. It does not contain the detailed information about acceptance criteria or specific study results to prove device performance. The letter only states that the device is "substantially equivalent" to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the text provided. The document primarily focuses on regulatory approval and classification, not on the individual studies proving performance.
§ 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).