(402 days)
The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgG kit is an in vitro qualitative assay for the detection of antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for Borrelia burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with Borrelia burgdorferi, the causative agent of Lyme Disease.
The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgG kil can be used at any time following onset of symptoms provided the EIA or IFA is positive or equivocal. It should be used for follow up when: 1) Only IgM antibodies were originally detected, 2) IgG antibodies were detected but were not considered significant by Western blot, or 3) previously tested seronegative individuals are shown to develop antibodies by EIA or IFA tests.
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The provided text is a 510(k) premarket notification approval letter for the "CDIL Human Lyme Borrelia burgdorferi Western Blot IgG kit". While it defines the "Indications For Use" for the device, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
The letter is a regulatory document confirming that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices, thereby permitting its marketing. It does not include the detailed performance data or study design that would be found in the actual 510(k) submission or supporting technical documentation.
§ 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).