510(k) DEN180028
DEN180028 is an FDA 510(k) premarket notification submitted by 23AndMe, Inc. for the device "23andMe Personal Genome Service (PGS) Pharmacogenetic Reports". The FDA issued a decision of De Novo granted on Oct 31, 2018. The device falls under product code QDJ (Direct-To-Consumer Access Pharmacogenetic Assessment System), a Class II device regulated under 21 CFR 862.3364. 23AndMe, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- DENG (De Novo granted)
- Decision Date
- Oct 31, 2018
- Date Received
- Jun 5, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Direct-To-Consumer Access Pharmacogenetic Assessment System
- Device Class
- Class II
- Regulation Number
- 862.3364
- Review Panel
- CH
- Submission Type
- 510(k)
A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only, and is intended for direct access testing by lay users.