Oragene Clearance Shows DNA Stabilization is Class II

Thursday, December 08, 2011

"[T]he U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for DNA Genotek’s Oragene•Dx collection device. Oragene•Dx is the first and only saliva DNA collection and stabilization device to receive 510(k) clearance."
—DNA Genotek press release

The Oragene clearance confirms what many of us have discussed in private, blogged about or secretly suspected: nucleic acid stabilization is a big enough claim to turn an ordinary Class I sample collection tube into a Class II medical device.

This decision is going to upset a few apple carts, particularly in the DTCG world. It's been an open secret that DTCG depends, to some extent, on the ambiguity of this device's classification status. Not everyone has gotten that memo, of course, and some silly things have been said in the meantime.

DTCG executives waking up this morning can no longer depend on this ambiguity. So they're left with four options:

  • Thank your lucky stars you already have a deal with DNA Genotek
  • Re-validate your test to work with Oragene
  • Push your vendor to obtain clearance for your un-cleared sample collection device
  • Hope that FDA doesn't seize on the obvious opportunity for enforcement

One way or another, it should be an interesting next few days for all concerned.

Tags: 510(k), FDA, LDTs

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