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The Viramed Biotech Borrelia B31 IgG ViraBlot® 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 Western blot assay are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech Borrelia B31 IgG Virablot® can be used anytime after onset 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 a Western blot, 2) IgG antibodies were found by Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested seronegative individuals are shown to develop antibodies by an EIA or IFA test.

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The user is asking for information about the acceptance criteria and study details for the "Borrelia B31 IgG Virablot®" device as outlined in the provided FDA 510(k) submission document. However, the provided text does not contain any information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is an FDA clearance letter for a 510(k) submission, confirming that the device, Borrelia B31 IgG Virablot®, is substantially equivalent to legally marketed predicate devices. It also includes the "Indication for Use" statement.

Therefore, I cannot fulfill the request using only the provided text.

To provide the requested information, I would need access to the actual 510(k) submission document, specifically the sections detailing the clinical and analytical studies, performance data, and validation methods.

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