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 informati

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.