PTA — Genetic Variant Detection And Health Risk Assessment System Class II
Classification Details
- Product Code
- PTA
- Device Class
- Class II
- Regulation Number
- 866.5950
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241456 | targeted genomics | GlutenID Celiac Genetic Health Risk Test | January 7, 2025 |
| K221420 | progenika biopharma s.a., a grifols | AlphaID At Home Genetic Health Risk Service | October 27, 2022 |
| K192073 | helix opco | Helix Genetic Health Risk App for late-onset Alzheimers disease | December 23, 2020 |
| K192944 | ancestry genomics | AncestryDNA Factor V Leiden Genetic Health Risk Test | August 13, 2020 |
| DEN160026 | 23andme | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Th | April 6, 2017 |