(13 days)
The REAADS Anti-Phosphatidylserine Semi-Quantitative Test Kit is an in vitro diagnostic assay for the I ho Keria and semi-quantitation of IgA anti-phosphatidylserine antibodies in human serum or plasma in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).
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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.
The document is an FDA 510(k) clearance letter for the "REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit." It indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.
However, the letter does not include:
- A table of acceptance criteria or reported device performance.
- Details of any specific study (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information about MRMC comparative effectiveness studies or standalone algorithm performance.
- Sample sizes for training sets.
The only technical information provided is the "Indications for Use" statement, which describes what the device is for but not how its performance was validated against specific criteria. To answer your questions, you would need access to the actual 510(k) submission document or a more detailed performance study report, which is not part of this clearance letter.
§ 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).