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The Viramed Biotech AG Borrelia B31 IgG ViraStripe® is an in vitro qualitative assay for the detection of IgG antibodies to 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 EIA 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 discasc. The Viramed Biotech AG Borrelia B31 IgG ViraStripe® can be used anytime after onset of symptoms provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in an line blot assay or Western blot, 2) IgG antibodies were found by line blot or Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested sero-negative individuals are shown to develop antibodies by an EIA or IFA test.

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This document is a 510(k) premarket notification FDA approval letter for the Borrelia B31 IgG ViraStripe device. It does not contain the detailed study results, acceptance criteria, or performance data that would allow a complete answer to your request. The letter confirms substantial equivalence but does not provide the underlying data.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, ground truth establishment, or multi-reader multi-case studies based solely on the provided text.

To answer your questions thoroughly, I would need access to the actual 510(k) summary document (K092693) which typically contains the study design, results, and acceptance criteria for in vitro diagnostic devices.

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