(148 days)
The Zeus Scientific, Inc., B. burgdorferi Western Blot Test System is designed for the qualitative detection of IgM class antibodies to specific proteins associated with B. burgdorferi, the causative agent of Lyme Disease. This test system is intended to be used for testing human serum samples which have been found to be positive or equivocal by an EIA or IFA screening procedure. The test is therefore intended to provide supportive evidence of infection with Borrelia burgdorferi.
Borrelia burgdorferi IgM Western Blot Test System
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria in the requested format. The document is an FDA 510(k) clearance letter confirming that the Borrelia burgdorferi IgM Western Blot Test System is substantially equivalent to legally marketed predicate devices. It does not include details on specific acceptance criteria for performance, the study design, sample sizes, expert qualifications, or ground truth establishment.
§ 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).