(14 days)
The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semiquantitation of IgA anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
The REAADS IgA anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "REAADS IgA anti-B2GPI Test Kit." It confirms the device's substantial equivalence to a legally marketed predicate device but does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria.
Therefore, I cannot provide the requested information based on the given text.
The document primarily focuses on regulatory clearance and does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Information on experts, adjudication methods, or ground truth establishment.
- Details of MRMC comparative effectiveness or standalone studies.
- Sample size or ground truth establishment for a training set.
§ 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).