# DEN160026: Genetic Variant Detection And Health Risk Assessment System

- Pathway: De Novo
- Applicant: unknown
- Decided: —
- 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K221420: AlphaID™ At Home Genetic Health Risk Service (2022), 0 descendants of its own
- K192073: Helix Genetic Health Risk App for late-onset Alzheimer’s disease (2020), 0 descendants of its own
- K192944: AncestryDNA Factor V Leiden Genetic Health Risk Test (2020), 0 descendants of its own

Source page: https://510kreport.com/device/DEN160026
Methodology: https://510kreport.com/methodology