Pharmacogenetics · 510(k) K221885
23andMe: SLCO1B1 report with drug information
FDA record K221885: 510(k) cleared on October 26, 2022 for 23andMe. It was decided after FDA last updated its Direct-to-Consumer Tests table (December 20, 2019); it appears in FDA's device database.
- FDA device name
- 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
- Applicant (as FDA lists it)
- 23AndMe, Inc.
- FDA decision
- Substantially equivalent (cleared)
- Decision date
- October 26, 2022
- Product code
- QDJ
- Regulation
- 21 CFR 862.3364
FDA database entry · FDA 510(k) file (PDF) · openFDA record
What the authorization says it may report
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.
Stated limitations
This test does not determine if a person will or will not respond to a particular therapeutic.
For CYP2C19 only: This test does not provide interpretive drug information for the CYP2C19 *3/*17 genotype or other CYP2C19 genotype combinations where the predicted metabolizer profile cannot be interpreted.
Do not use your results to start, stop or change any course of treatment.
FDA classifies this test type under 21 CFR 862.3364, which says: “A pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system intended to detect nucleic acid variants isolated from human specimens for the purpose of assessing the presence of genetic variants that impact the metabolism, exposure, response, risk of adverse events, dosing, or mechanisms of prescription or over-the-counter medications.” (21 CFR 862.3364)
Also in the FDA file
to provide interpretive drug information to one specific medication (simvastatin), and to remove the limitation language requiring confirmatory testing in the 23andMe pharmacogenetics report for SLCO1B1.
What this record doesn't tell you
An FDA record says what a test was authorized to report on the decision date. It doesn't say whether the product is still sold, what it costs, or which version a kit in a store uses. Check the company's own label and report for the current claims.
FDA's general advice on direct-to-consumer tests: “Do not make any dietary or health-related decisions without first discussing your test results with your health care provider.” (U.S. Food and Drug Administration)
Other pharmacogenetics records
23andMe: Pharmacogenetic reports, eight genes
How the body processes some medications (CYP2C19, CYP2C9, CYP3A5, UGT1A1, DPYD, TPMT, SLCO1B1, CYP2D6)
23andMe: CYP2C19 report with drug information
How the body processes some medications (CYP2C19: citalopram, clopidogrel)