Did Theranos have a test FDA cleared? Vox writes in The Theranos controversy, explained: > After all, the evidence on this wasn't public: The Food and Drug Administration (FDA) hadn't cleared Theranos's tests. On the other hand Theranos claims that the FDA did give it a clearance for it's herpes simplex virus test: > FDA has already cleared one of those tests, including our underlying test systems and Nanotainer™ tubes, for use in detecting the herpes simplex virus (HSV-1). Is the Vox summary that says that the FDA didn't gave any clearance wrong?

On 02 July 2015, the FDA made a decision concerning the Theranos Herpes Simplex Virus-1 IgG Assay.

The 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY concludes:

> The submitted information in this premarket notification is complete and supports a substantial equivalence decision.