Did Theranos have a test FDA cleared?

Question

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?

The Vox article you reference says: "...In a follow-up, the Wall Street Journal confirmed that the FDA had pressured Theranos to stop using its Edison technology on *almost all of its blood tests save for one* (a test for Type 1 herpes simplex) because of concerns about the machine's accuracy...." — President James K. Polk, Dec 20 '15 at 20:02
@JamesKPolk : The article doesn't go into detail of why the FDA retreated one test at that point differently than the others. The FDA doesn't automatically ban tests for which the FDA get's no evidence that they work. — Christian, Dec 20 '15 at 20:26

score 2 · Accepted Answer · answered Dec 17 '15 at 18:22

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.

Did Theranos have a test FDA cleared?

1 Answers1