(203 days)
This kit is intended for screening of antibodies to intra-epidermal antigens or basement membrane zones in human serum as an aid in the diagnosis of pemphigus and bullous pemphigoid respectively. It can also be used for screening of endomysial antibodies as an aid in the diagnosis of celiac disease.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for the "Monkey Oesophagus IFA Kit." This document does not contain the detailed information required to describe acceptance criteria and the study proving the device meets them.
The letter is a regulatory approval document, stating that the device is substantially equivalent to legally marketed predicate devices. It confirms the device can be marketed. It does not include information about the performance evaluation study, such as acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested table and details based on the input text. The input is a clearance letter, not a device performance study report.
§ 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).