Devices · 23andMe, Inc.

23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia

23andMe, Inc. is listed for 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia (DEN160026). The FDA list gives April 6, 2017 as the date of the final decision. The lead panel is Immunology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code PTA as “Genetic Variant Detection And Health Risk Assessment System”: 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 person’s overall risk of developing a disease. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160026

Official FDA database record

Date of final decision

April 6, 2017

Company on the FDA list

23andMe, Inc.

Lead panel

Immunology

Primary product code

PTA

openFDA device name for the code

Genetic Variant Detection And Health Risk Assessment System

Device class

2

Regulation number

866.5950

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned