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The Trinity Biotech Rotavirus EIA kit is intended for the detection of rotavirus antigen in human fecal specimens and is used as an aid in the diagnosis of acute gastroenteritis caused by rotavirus in children and infants. The performance characteristic was not determined in the elderly population.

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I cannot fulfill this request. The provided text is a regulatory document from the FDA regarding a medical device, the "Trinity Biotech's Rotavirus EIA". It is a clearance letter for a 510(k) submission and discusses substantial equivalence, regulatory classifications, and general controls.

The document does not contain any information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria (beyond stating that the device is substantially equivalent to a predicate).
• Sample sizes for test sets or training sets.
• Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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