510(k) DEN160026
DEN160026 is an FDA 510(k) premarket notification submitted by 23AndMe, Inc. for the device "23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia". The FDA issued a decision of De Novo Granted on April 6, 2017. The device falls under product code PTA (Genetic Variant Detection And Health Risk Assessment System), a Class II device regulated under 21 CFR 866.5950. 23AndMe, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 6, 2017
- Date Received
- June 28, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Genetic Variant Detection And Health Risk Assessment System
- Device Class
- Class II
- Regulation Number
- 866.5950
- Review Panel
- IM
- Submission Type
A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users of lifestyle choices and/or encourage conversations with a healthcare professional. This assessment system is for over-the-counter use. This device does not determine the persons overall risk of developing a disease.