From my understanding, for FDA 510(k) clearance HGR has to prove...

From my understanding, for FDA 510(k) clearance HGR has to prove substantial equivalence to a device that already has FDA clearance.

I was wondering if anyone knew what the likely devices HGR is comparing Oraline to. As the first saliva test for multiple drugs, what do we compare it to?

I currently have a small position, and just want to get some idea of how likely the FDA clearance is before I consider a larger position.

Thanks