# K193492: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

- Pathway: 510(k) (Traditional)
- Applicant: 23AndMe, Inc.
- Decided: Aug 17, 2020 after 244 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
Longest line of descent: 1 generation back to DEN180028 (2018). 1 ancestor in all.
1 later device descends 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)
- DEN180028: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports, 23AndMe, Inc. (2018) Summary page 6.

## Most influential descendants
- 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 Pharmacogenetic Reports are indicated for reporting of the following variants: Gene: CYP2C19 Variant(s): *2, *3, *17 Gene: CYP2C9 Variant(s): *2, *3, *5, *6, rs7089580 Gene: CYP3A5 Variant(s): *3 Gene: UGT1A1 Variant(s): *6, *28 Gene: DPYD Variant(s):*2A, rs67376798 Gene: TPMT Variant(s): *2, *3C Gene: SLCO1B1 Variant(s): *5 Gene: CYP2D6 Variant(s): *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. The 23andMe Personal Genome Service pharmacogenetic reports for CYP2C9, CYP3A5, UGT1A1, DPYD, TPMT, SLCO1B1 and CYP2D6 describe 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. 23andMe Personal Genome Service pharmacogenetic reports for CYP2C19 describes if a person has variants associated with metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of the identified metabolizer phenotype on citalopram and clopidogrel therapy. 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/K193492
Methodology: https://510kreport.com/methodology