Has Trak been evaluated by the U.S. Food & Drug Administration (FDA)?

Yes.  We proudly received FDA 510k clearance for Trak as a class II, over-the-counter in vitro diagnostic system (K153683, issued May 2016).  Our FDA trials included a 239 subject, 3 site clinical study demonstrating that the Trak system meets the accuracy of gold standard laboratory semen analysis, and is easy to use and understand by lay subjects.  

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