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.  

Have more questions? Submit a request


Article is closed for comments.