# K192944: AncestryDNA Factor V Leiden Genetic Health Risk Test

- Pathway: 510(k) (Traditional)
- Applicant: Ancestry Genomics, Inc.
- Decided: Aug 13, 2020 after 300 days
- Product code: PTA (Genetic Variant Detection And Health Risk Assessment System)
- Device class: 2
- Regulation: 21 CFR 866.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160026: Genetic Variant Detection And Health Risk Assessment System Summary page 7.

## Indications for use
The AncestryDNA Factor V Leiden Genetic Health Risk Test for Hereditary Thrombophilia uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from human saliva collected from individuals 18 years and older with the AncestryDNA Saliva Collection Kit for the purpose of reporting and interpreting Genetic Health Risks (GHR). The AncestryDNA Factor V Leiden Genetic Health Risk Report for Hereditary Thrombophilia is indicated for reporting of the Factor V Leiden variant in the F5 gene. This report describes if a person has variants associated with a higher risk of developing harmful blood clots, but it does not describe a person's overall risk of developing harmful blood clots. This test is most relevant for people of European descent.

Source page: https://510kreport.com/device/K192944
Methodology: https://510kreport.com/methodology