Laboratory_medicine
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
23andMe, Inc.
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.
FDA Submission Metadata
- Submission number
- DEN160026
- Decision date
- April 2017
- FDA panel
- Immunology
- Product code
- PTA
- Clinical task (npj)
- predictive
- Data modality (npj)
- Omics
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.