(356 days)
The Viramed Biotech AG Borrelia B31 IgM ViraStripe® is an in vitro qualitative assay for the detection of IgM antibodies against Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an ElA or IFA test procedure for B. burgdorferi antibodies. Positive results from this line blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech AG Borrelia B31 IgM ViraStripe® can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. Patients who are positive by IgM but not IgG should have the test repeated a few weeks later if they remain ill. If they are still positive only by IgM and have been ill longer than one month, this is likely a false positive.
Not Found
The document provided is a 510(k) clearance letter from the FDA for a device called "Borrelia B31 IgM ViraStripe®." It primarily details the regulatory approval process and includes the Indications for Use. However, it does not contain the specific information required to answer your request about acceptance criteria, reported device performance, study details (sample sizes, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or ground truth methodology.
This type of document typically references the studies conducted, but does not present their detailed findings or methodologies within the letter itself. To obtain that information, one would generally need to review the original 510(k) submission or supporting documents, which are not included here.
Therefore, I cannot provide the requested information based solely on the provided text.
§ 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).