It will be interesting to see if the FDA comes down on this. On the one hand, they aren't selling anything, yet. On the other, they are making promises about efficacy for the initial users.
It looks like they are in the data gathering phase for a 510(k), as an exempt IVD. From their site:
"Cue Inc. will be conducting tests and collecting information and data from a number of individuals to ultimately support submission to FDA of a pre-market notification 510(k). We hope that you will consider voluntarily participating in these tests. These tests are exempt for Investigational Device Exemption requirements because the testing (a) is noninvasive; (b) does not require an invasive sampling procedure that presents significant risk; (c) does not by design or intention introduce energy into a subject, and (d) is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure."
I'm curious what they'll cite for predicate devices.
