# K221885: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

- Pathway: 510(k) (Traditional)
- Applicant: 23AndMe, Inc.
- Decided: Oct 26, 2022 after 119 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: 2 generations back to DEN180028 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193492: 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports, 23AndMe, Inc. (2020) Summary page 6.

## 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: 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): c.521T>C (rs4149056) 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 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 pharmacogenetics report 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. 23andMe Personal Genome Service pharmacogenetics report for SLCO1B1 describes if a person has variants associated with the processing of some therapeutics and provides interpretive drug information regarding the potential effect of the identified transport function phenotype on simvastatin 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/K221885
Methodology: https://510kreport.com/methodology