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The GSA kit is for the evaluation of human semen and provides a set of reagents to evaluate semen quality by measuring five parameters, recommended by the World Health Organization (WHO), that are used to determine whether infertility is caused by abnormalities of one or more of them. The parameters include: Sperm Count, sperm motility, sperm viability, white blood cell (WBC) count, and Sperm head morphology (the subject of this 510(k) submission.

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This looks like a 510(k) clearance letter for a medical device called the "General Semen Analysis Kit" (GSA Kit). However, the provided text does not contain the acceptance criteria or a study detailing device performance against those criteria.

The document primarily states that the FDA has reviewed the 510(k) premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It also outlines the intended use of the GSA kit for evaluating human semen based on five WHO-recommended parameters (Sperm Count, sperm motility, sperm viability, white blood cell (WBC) count, and Sperm head morphology).

To answer your questions, I would need access to the actual 510(k) submission document or a summary of its contents that details the performance studies.

Therefore, I cannot provide the requested information based on the provided input.

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