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The Viramed Biotech AG Borrelia B31 Viro qualitative protein nicroaray assay for the detection of IgM antibodies to Borreia burgdorfer in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EA or FFA test procedure for B. burgdorferi antibodies. Positive essay are supportive evidence of infection with B. burgdorfer, the causative agent for Lyme disease.

The Viramed Biotech AG Borrelia B31 ViraChip® IgM Test must be used with a ViraChip® Reader and the ViraChip® Software.

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I am sorry, but the provided text does not contain the information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter for a medical device (Borrelia B31 ViraChip IgM Test Kit), which confirms that the FDA has determined the device is substantially equivalent to a legally marketed predicate device.

However, it does not contain the following specific details required to answer your request:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth establishment.
• Adjudication method.
• Information on Multi-Reader Multi-Case (MRMC) studies or effect sizes.
• Information on standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

This document is an administrative clearance letter, not a clinical study report or a summary of performance data. To get the requested information, you would typically need to review the device's 510(k) submission summary or a separate clinical study publication.

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