23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia is an AI-enabled medical device from 23andMe, Inc. that the U.S. FDA granted through De Novo DEN160026 on April 6, 2017. Its lead review panel is Immunology and its primary product code is PTA (Genetic Variant Detection And Health Risk Assessment System).
See also all FDA AI clearances in 2017.
Key facts
| Submission number | DEN160026 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | 23andMe, Inc. |
| Lead review panel | Immunology |
| Primary product code | PTA — Genetic Variant Detection And Health Risk Assessment System |
| Applicant (openFDA) | 23AndMe, Inc. |
| Applicant location | Mountain View, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 866.5950 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia went through this pathway (DEN160026).
openFDA lists it as a Class 2 device under 21 CFR 866.5950. Class II devices are moderate risk and are subject to general and special controls.
Product code PTA covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. 23andMe, Inc. has 1 AI-enabled device on the list, and the Immunology panel accounts for 1 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.