(107 days)
The in-vitro measurement of anticardiolipin antibodies in human serum, as an aid in the diagnosis of antiphospholipid syndrome (APS).
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device called "Anticardiolipin IgM Screen EIA Kit." This document does not contain details about acceptance criteria or a study proving the device meets those criteria, nor does it describe AI-related performance studies.
The letter primarily:
- Confirms receipt and review of the 510(k) submission.
- States that the device is substantially equivalent to legally marketed predicate devices.
- Outlines post-market regulatory requirements and general controls provisions of the Act.
- Provides contact information for further inquiries.
- Mentions the device's indications for use (in the enclosure).
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI-related comparative effectiveness studies from the provided text.
§ 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).