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The GIARDIA II test is an enzyme immunoassay for the qualitative detection of Giardia lamblia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. FOR IN VITRO DIAGNOSTIC USE.

The GIARDIA II test is an enzyme immunoassay.

This document does not contain the detailed study information, acceptance criteria, or performance data for the GIARDIA II device. The provided text is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device. It states the intended use and regulatory classification but does not include the specifics of the performance study that would demonstrate it meets acceptance criteria.

Therefore, I cannot fulfill the request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone performance details.
7. Type of ground truth used for the test set.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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