510(k) K192944
K192944 is an FDA 510(k) premarket notification submitted by Ancestry Genomics, Inc. for the device "AncestryDNA Factor V Leiden Genetic Health Risk Test". The FDA issued a decision of Substantially Equivalent on Aug 13, 2020. 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. Ancestry Genomics, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 2020
- Date Received
- Oct 18, 2019
- Clearance Type
- Traditional
- 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
- 510(k) Exempt
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.