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The Zeus Scientific, Inc. Herpes Simples Virus (HSV) -1 and/or HSV-2 IgM ELISA Test System is intended for the qualitative detection of IgM antibodies to Herpes Simplex Virus type 1 and 2 in human serum. The test system is designed to detect IgM antibody to HSV-1 or HSV-2, but can not disginguish between the two IgM antibodies. The test system is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV-1 and/or HSV-2.

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This document is a 510(k) clearance letter from the FDA for a diagnostic device, not a study report. As such, it does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study demonstrating new performance characteristics against explicitly defined acceptance criteria in the way a pivotal clinical trial report would.

Therefore, I cannot populate the requested table and answer the questions based solely on the provided text. The document confirms that a study was conducted to support the 510(k) submission, but it does not describe the specifics of that study.

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