(402 days)
The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgM kit is an in vitro qualitative assay for the detection of antibodies to Borrelia burgdorferi in human serum. II is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with B.burgdorferi, the causative agent of Lyme disease.
l he Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorfen IgM Western Blol kil can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorfen infection. After this early period, infected patients are usually found to be Western Blot positive for IgG. A positive IgM test alone is not rocommended for use in determining aclive disease in persons with illness of longer than one month.
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The provided document is an FDA 510(k) clearance letter for the "Human Lyme Borrelia burgdorferi IgM Western Blot Kit." This document does not contain any information regarding acceptance criteria, device performance, study details (sample size, provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance), or training set information.
The letter confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory obligations. It states the indications for use of the device but offers no data from performance studies.
Therefore, I cannot provide the requested information based on the given input.
§ 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).