(121 days)
The aCL/aPS®FACS Kit is and assay for the semi-quantitative determination of antiphospholipid (anticardiolipin-aCL and antiphosphatidy/serine-aPS) antibodies to be used in the aid of the diagnosis of the Antiphospholipid Syndrome (APS). APS is defined as a disorder of recurrent thrombosis, pregnancy loss and/or thrombocytopenia with persistent positive antiphospholipid tests.
ACL/aPS FACS Kit
This document is a marketing clearance letter from the FDA for the ACL/APS FACS Kit. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory requirements and provides contact information for various FDA offices.
To provide the requested information, I would need to analyze a different document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) submission itself, if available.
§ 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).