(125 days)
An indirect immunofluorescence assay (IFA) for the detection of and semi-quantitation of endomysial antibodies (EMA) in human serum to aid in the diagnosis of Celiac Disease (CD) and Dermatitis Herpetiformis (DH) in combination with other clinical and other laboratory findings.
An indirect immunofluorescence assay (IFA) for the detection of and semi-quantitation of endomysial antibodies (EMA) in human serum.
The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications.
The letter acknowledges the device's substantial equivalence to a predicate device and states its intended use, but it does not include the results of performance studies that would typically be found in the 510(k) summary or the full submission.
Therefore, I cannot provide the requested information from the given text.
If you have access to the actual 510(k) submission (K060157), specifically the "Device Description," "Performance Characteristics," or "Summary of Nonclinical and/or Clinical Studies" sections, that is where you would find the details needed to answer your questions.
§ 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).