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The Zeus Scientific, Inc. AtheNA Multi-Lyte® VZV IgG Test System is a microparticle-based immunoassay intended for the quantitative determination of IgG class antibodies to Varicella-Zoster Virus in human serum. The AtheNA Multi-Lyte® VZV IgG Test System is intended for the qualitative determination of a previous infection with Varicella-Zoster Virus.

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I am sorry, but the provided text does not contain the detailed study information required to fulfill your request. The document is an FDA 510(k) clearance letter for a medical device (AtheNA Multi-Lyte® VZV IgG Test System), which indicates that the device has been found substantially equivalent to a legally marketed predicate device.

While it mentions the "Indications For Use" and the type of immunoassay, it does not include:

• A table of specific acceptance criteria.
• Reported device performance metrics (sensitivity, specificity, accuracy, etc.) against those criteria.
• Details about the study design that would prove the device meets acceptance criteria (e.g., sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for test/training sets, or training set sample sizes).

Such details are typically found in the 510(k) submission itself or in separate clinical study reports, which are not part of this clearance letter.

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