Unicorns, Santa Claus and Instrument-Only Clearances

Tuesday, May 04, 2010

"According to the FDA's indications of use, the BeadXpress system... is an in-vitro diagnostic device intended for the simultaneous detection of multiple analytes in a DNA sample utilizing VeraCode holographic microbead technology."
—Illumina press release, 5/4/10

I've gotten quite a few calls today on this announcement. At first glance, it appears that Illumina is announcing something very special: the elusive instrument-only clearance.  Either FDA has secretly turned 180 degrees on everything they've been saying to me the last few years or Illumina has truly pulled off a very special feat.

We won't get a chance to see the decision summary for a few more days, but I feel pretty comfortable calling this one. It's a regular test clearance from which the company is attempting to squeeze the maximum PR value.

Besides the fact that this is the only explanation that makes sense, there are some clues in what's already been written on this.  For example: the GenomeWeb story on this clearance says the instrument was submitted "with an undisclosed genetic test." That's just what you would expect to be the case, so it seems sensible to assume that this is the case.  It's the quickest route between RUO and being able to use the phrase "FDA cleared".

Getting a clearance on your instrument is a pretty big deal and Illumina should be proud of their accomplishment. Let's be clear, though: the world has not turned topsy-turvy today.

This is not an instrument-only clearance and they're really flirting with disaster by suggesting that it is. It's bad enough to make such broad claims in a press release. Essentially claiming that you got FDA to re-write the rules for you is the kind of thing you can expect will be brought to their attention.  It's not an auspicious way to demonstrate your new regulatory seriousness.

I would expect to see a "clarifying" announcement some time very soon.


Tags: 510(k), Advertising and Promotion, Best Practices, CDRH, FDA, IVD, LDTs

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