(125 days)
This test system is designed for the manual or automated, qualitative, for the presumptive (first-step) detection of IgG and/or IgM antibody to Borrelia burgdorferi in human serum from patients with history, signs, or symptoms suggestive of infection with B. burgdorferi. The test system is intended to by used as an aid in the diagnosis of Lyme disease, and is for in vitro diagnostic use.
Not Found
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the "Aptus (Automated) Application for the B. burgdorferi Antibody ELISA Test System." This document grants market clearance based on substantial equivalence to a predicate device.
The letter itself does not contain the acceptance criteria or the study details that prove the device meets these criteria. Such information would typically be found in the 510(k) submission summary or a separate technical document, which are not provided here.
Therefore, I cannot extract the requested information from the given text. The document only confirms that the device has been reviewed and found substantially equivalent for its stated indications for use.
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).