510(k) DEN140044
DEN140044 is an FDA 510(k) premarket notification submitted by 23AndMe for the device "23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)". The FDA issued a decision of De Novo granted on Feb 19, 2015. The device falls under product code PKB (Autosomal Recessive Carrier Screening Gene Mutation Detection System), a Class II device regulated under 21 CFR 866.5940. 23AndMe has 8 other 510(k) clearances on record.
Clearance details
- Decision
- DENG (De Novo granted)
- Decision Date
- Feb 19, 2015
- Date Received
- May 29, 2014
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Autosomal Recessive Carrier Screening Gene Mutation Detection System
- Device Class
- Class II
- Regulation Number
- 866.5940
- Review Panel
- PA
- Submission Type
- 510(k)
Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human peripheral whole blood or saliva specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing.