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• 1. For in vitro diagnostic use only.
• 2. For the qualitative and semi-quantitative detection of IgG antibodies to mumps virus in human serum by enzyme immunoassay.
• 3. Individual specimens may be used for the determination of immune status.
• 4. Paired (acute / convalescent) sera, may be used to demonstrate seroconversion or significant rises in antibody level, as an aid in the diagnosis of primary infection.
• 5. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

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The provided text for device K980059 is a 510(k) clearance letter from the FDA for the "SeraQuest Mumps IgG" device. This document primarily focuses on regulatory approval and does not contain the detailed study information needed to answer your questions regarding acceptance criteria, performance data, sample sizes, ground truth establishment, or expert qualifications.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been determined to be as safe and effective as a previously cleared device. However, it does not include the actual study data, acceptance criteria, or performance metrics from the studies submitted by Quest International, Inc. to demonstrate this substantial equivalence.

Therefore, I cannot provide the requested information based on the given text. To answer your questions, I would need access to the full 510(k) summary or the original study reports submitted to the FDA by the manufacturer.

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