# K192073: Helix Genetic Health Risk App for late-onset Alzheimer’s disease

- Pathway: 510(k) (Traditional)
- Applicant: Helix Opco, LLC
- Decided: Dec 23, 2020 after 509 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 5.

## Indications for use
The Helix Genetic Health Risk App (HRA) uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from human saliva collected from individuals ≥18 years with Oragene®•Dx OGD-610 for the purpose of reporting and interpreting Genetic Health Risks (GHR): The Helix Genetic Health Risk App (HRA) for late-onset Alzheimer’s disease is indicated for reporting of the e2/e2, e2/e3, e3/e3, e2/e4, e3/e4 and e4/e4 genotypes in the APOE gene. The report describes if a person's genetic result is associated with an increased or decreased risk of developing late-onset Alzheimer’s disease. The e2 and e4 variants included in this report are found and have been studied in many ethnicities. Detailed risk estimates have been studied the most in people of European descent. The Helix Genetic Health Risk App (HRA) is to be used with the Helix Laboratory Platform.

Source page: https://510kreport.com/device/K192073
Methodology: https://510kreport.com/methodology