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• For the qualitative detection of IgM antibodies to CMV in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection.
• A positive result is presumptive for the detection of anti-CMV antibodies and presumptive for the diagnosis of acute or recent CMV infection.
• Useful for the above indications, with specimens obtained from women of childbearing age.
• For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the SeraQuest CMV IgM device, which primarily concerns the substantial equivalence determination to a legally marketed predicate device.

The document discusses:

• The FDA's review and determination of substantial equivalence for the SeraQuest CMV IgM device.
• Regulatory classifications and general controls applicable to the device.
• CLIA complexity categorization.
• Contact information for various FDA offices.
• The intended uses (indications for use) of the device.

There is no mention of specific performance metrics, acceptance criteria, study design, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies as requested in your prompt.

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