510(k) DEN140044
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 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
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.