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QwikCheck™ Test Strips are for in vitro diagnostic use for the determination of pH and leukocytes (WBCs) in semen. Test results are determined by comparing the color of the test patches to the color chart provided on the bottle label. The test is for professional use only.

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This document is a 510(k) clearance letter for the QwikCheck™ Test Strips, which are reagent strips for semen analysis. However, it does not contain the detailed acceptance criteria and study data needed to fully answer your request.

Specifically, the letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about samples, experts, or ground truth establishment.
• Information regarding standalone performance, MRMC studies, or training set details.

The letter focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report. To get the information you're looking for, you would typically need to review the original 510(k) submission document itself, or any accompanying performance study reports that were submitted to the FDA for review.

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