PTA
5 FDA 510(k) clearances · Product code
282 daysmedian time to decision
509 days90th percentile
5clearances measured
FDA profile
- Official device name
- Genetic Variant Detection And Health Risk Assessment System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5950
- Medical specialty
- Immunology
- FDA definition
- 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.
Download CSV table Client report (share link) ◉ Watch
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Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| GlutenID Celiac Genetic Health Risk Test (K241456) | Targeted Genomics, LLC | 2025-01-07 | + Add |
| AlphaID™ At Home Genetic Health Risk Service (K221420) | Progenika Biopharma S.A., A Grifols Company | 2022-10-27 | + Add |
| Helix Genetic Health Risk App for late-onset Alzheimer’s disease (K192073) | Helix Opco, LLC | 2020-12-23 | + Add |
| AncestryDNA Factor V Leiden Genetic Health Risk Test (K192944) | Ancestry Genomics, Inc. | 2020-08-13 | + Add |
| 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia (DEN160026) | 23AndMe, Inc. | 2017-04-06 |
Track PTA automatically
Every clearance here is in the API, with alerts when new ones post.