UPDATED @ 4:33 PST - 23andMe clarified that they submitted a de novo 510(k). Bloomberg Businessweek reports that they submitted data on seven tests. All snark aside, a clearance of this type would represent a truly significant accomplishment. I'm still taking wagers, but must respectfully retract my speculation on what would happen if this were simply a pre-IDE.
"The 510(k) documentation provided to the FDA builds upon the company’s scientifically sound practices by demonstrating the clinical and analytical validity of its reporting."
—23andMe Press Release
Today, 23andMe announced they sent something to FDA for... something. It sounded like a 510(k), but maybe that's not even right. What they actually said they submitted was the "first round of 510(k) documentation" so maybe that's a pre-IDE? Who knows.
We don't know anything about what actually happened and neither does anyone else reading their wonderfully non-speciifc press release. So the only thing we can do at this point is wait 90 days and see when the next announcement is. The three options are:
- Clearance Granted
Hooray for 23andMe! They managed to develop a system and provide sufficient documentation to get cleared for a reasonable intended use. If anyone is looking to stake money on this being the outcome, please let me know.
- Application Withdrawn / Rejected
D'oh! Turns out FDA doesn't clear diagnostics on the basis of literature and self-reported data, nor are they likely to regard many of 23andMe's intended uses as Class II products. But I'm not counting on this either. The one I'm holding out for is...
- Total Silence
Nothing to see here, folks. It turns out it wasn't a 510(k) at all, but a pre-IDE that was misleadingly characterized as something more significant. This would be pretty embarrassing, since one of the points of a pre-IDE is to confirm classification and they've essentially pre-announced the ruling they hope FDA will make. That's a huge rookie error and not a great way to build goodwill at the agency.