510(k) · Cleared
ClearedHelix Genetic Health Risk App for late-onset Alzheimer’s disease
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helix Opco, LLC · PTA Genetic Variant Detection And Health Risk Assessment System
Cleared on Dec 23, 2020 as substantially equivalent to DEN160026 (unknown applicant, ) after a 509-day review.
- Decided
- Dec 23, 2020
- Review
- 509 days
- Class
- Class II
- Product code
- PTA
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PTA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PTA device
- #1 K221420 AlphaID™ At Home Genetic Health Risk Servicescore 4.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN160026 | Genetic Variant Detection And Health Risk Assessment SystemSummary page 5…h Risk Report for Differences Alzheimer’s disease Late-onset Alzheimer’s Disease (DEN160026) Intended Use / The Helix Genetic The 23andMe Personal Similar Indications for use Health Risk Ap… | |
| † | DEN190035 | Helix Laboratory Platform | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN160026.
How does its category compare?
All PTA devicesPTA Genetic Variant Detection And Health Risk Assessment System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PTA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PTA
Too few PTA 510(k)s in any year since 2007 to give a median.
Recalls per year · PTA
No recall names PTA since 2007.
Adverse event reports per year · PTA
1in 2024
MAUDE reports naming product code PTA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (138 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192073: Helix Genetic Health Risk App for late-onset Alzheimer’s disease.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192073
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026