Search Results

The Viramed Biotech Borrelia B31 IgM ViraBlot® is an in vitro qualitative assay for the detection of IgM antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples which have been found insitive 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. The Viramed Biotech Borrelia B31 ViraBlot can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to be Western blot positive for IgG. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.

Not Found

Acceptance Criteria and Device Performance for Borrelia B31 IgM Virablot®

The provided document describes the FDA's substantial equivalence determination for the Borrelia B31 IgM Virablot®, stating it is substantially equivalent to legally marketed predicate devices. However, the document does not include specific acceptance criteria or details of a study that proves the device meets those criteria. It is a regulatory clearance letter rather than a detailed performance study report.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance from the provided text. The document outlines the "Indication for Use" (refer to page 2 and 3) which broadly defines the intended application of the device, but this is distinct from specific performance metrics and their associated acceptance thresholds.

Without that specific information, I cannot answer the remaining points of your request regarding:

• Sample size and data provenance for the test set
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

In summary, the provided FDA 510(k) clearance letter acknowledges the device's substantial equivalence but does not contain the detailed performance data, acceptance criteria, or study design information requested.

Ask a specific question about this device