# DEN180028: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

- Pathway: De Novo (Direct)
- Applicant: 23AndMe, Inc.
- Decided: Oct 31, 2018 after 148 days
- Product code: QDJ (Direct-To-Consumer Access Pharmacogenetic Assessment System)
- Device class: 2
- Regulation: 21 CFR 862.3364
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K193492: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (2020), 1 descendant of its own
- K221885: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports (2022), 0 descendants of its own

## Indications for use
The 23andMe Personal Genome Service (PGS) is a qualitative genotyping assessment system applied to genomic DNA isolated from human saliva collected using the Oragene Dx OGD-500.001 to simultaneously detect, report, and interpret genetic variants in a broad multigene test. The assessment system is intended to enable users to access information about their genetics that could aid discussions with a healthcare professional. The 23andMe Personal Genome Service Pharmacogenetic Reports are indicated for reporting of the following variants: Gene Variant(s) CYP2C19 *2, *3, *17 CYP2C9 *2, *3, *5, *6, rs7089580 CYP3A5 *3 UGT1A1 *6, *28 DPYD *2A, rs67376798 TPMT *2, *3C SLCO1B1 *5 CYP2D6 *2, *3, *4, *5, *6, *7, *8, *9, *10, *11, *15, *17, *20, *29, *35, *40, *41 This report is for over-the-counter use by adults over the age of 18 and provides genetic information to inform discussions with a healthcare professional about metabolism of therapeutics. This report describes if a person has variants associated with metabolism of some therapeutics, but does not describe if a person will or will not respond to a particular therapeutic, and does not describe the association between detected variants and any specific therapeutic. The PGS Pharmacogenetic Reports are not a substitute for visits to a healthcare professional. The information provided by this report should not be used to start, stop, or change any course of treatment.

Source page: https://510kreport.com/device/DEN180028
Methodology: https://510kreport.com/methodology