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FDA 510(k)

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

K-Number: K223597 · 2023-08-31

Applicant23AndMe, Inc.
Decision Date2023-08-31
Product CodeQAZ
Advisory CommitteeMG
DecisionSubstantially Equivalent

Device Summary

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is a medical device manufactured by 23AndMe, Inc.. It received FDA 510(k) clearance on 2023-08-31 under approval number K223597. The device is classified under product code QAZ. It was reviewed by the MG advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)?

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is a medical device that received FDA 510(k) clearance on 2023-08-31. It is manufactured by 23AndMe, Inc.. The 510(k) number is K223597.

When was 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) approved by the FDA?

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) received FDA 510(k) clearance on 2023-08-31, under approval number K223597.

What company makes 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)?

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is manufactured by 23AndMe, Inc..

What is the FDA product code for 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)?

The FDA product code for 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is QAZ.

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Related PubMed Literature

PMID: 41883556 A clinician's quick‑start guide to implementing digital health innovations in the NHS - with lessons from a UK-deployed AI stroke imaging decision-support software. Digital health (2026) PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026) PMID: 41638310 Lower Extremity Complications in Adults With Type 2 Diabetes Treated With Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter 2 Inhibitors, Dipeptidyl Peptidase-4 Inhibitors, and Sulfonylureas: An Emulated Target Trial. Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists (2026) PMID: 41453730 Validation of the SOPHiA DDM HRD Solution as a Companion Diagnostic for Poly (ADP-Ribose) Polymerase Inhibitor Access in Australia. The Journal of molecular diagnostics : JMD (2026)

Other Devices by 23AndMe, Inc.

DEN16002623andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia DEN18002823andMe Personal Genome Service (PGS) Pharmacogenetic Reports DEN17004623andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) K182784MUTYH-Associated Polyposis (MAP) K19349223andMe Personal Genome Service (PGS) Pharmacogenetic Reports K22188523andMe Personal Genome Service (PGS) Pharmacogenetic Reports

View all 8 devices →

Related Devices (Code: QAZ)

DEN17004623andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)23AndMe, Inc. K182784MUTYH-Associated Polyposis (MAP)23AndMe, Inc. K21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)23AndMe, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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