Product code PTA— Immunology
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
- Classification name
- Genetic Variant Detection And Health Risk Assessment System
- Device class
- Class 2
- Regulation
- 21 CFR 866.5950
- Advisory panel
- Immunology
- Total cleared
- 5
- First cleared
- Most recent
FDA classification 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.”
Market context for product code PTA
FDA has cleared devices under product code PTA between 2017 and 2025, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2022
- 2020
- 2017
Top applicants under product code PTA
Recent clearances under product code PTA
- K241456 — GlutenID Celiac Genetic Health Risk Test
- K221420 — AlphaID At Home Genetic Health Risk Service
- K192073 — Helix Genetic Health Risk App for late-onset Alzheimers disease
- K192944 — AncestryDNA Factor V Leiden Genetic Health Risk Test
- DEN160026 — 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
Data sourced from openFDA. This site is unofficial and independent of the FDA.