FDA 510(k)

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)

K-Number: K211499 · 2022-01-06

Decision Date2022-01-06

Product CodeQAZ

Advisory CommitteeMG

DecisionSubstantially Equivalent

Device Summary

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) is a medical device manufactured by 23AndMe, Inc.. It received FDA 510(k) clearance on 2022-01-06 under approval number K211499. 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 PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)?

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) is a medical device that received FDA 510(k) clearance on 2022-01-06. It is manufactured by 23AndMe, Inc.. The 510(k) number is K211499.

When was 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) approved by the FDA?

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) received FDA 510(k) clearance on 2022-01-06, under approval number K211499.

What company makes 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)?

23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) is manufactured by 23AndMe, Inc..

What is the FDA product code for 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)?

The FDA product code for 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) is QAZ.

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Related PubMed Literature

PMID: 41714355 The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer. Abdominal radiology (New York) (2026) PMID: 41671552 The Longevity of Mobile Apps for Cancer Recovery: Scoping Review. JMIR cancer (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 41153831 Molecular Mechanisms of Thyroid Hormone Signaling in Thyroid Cancer: Oncogenesis, Progression, and Therapeutic Implications. Biomedicines (2025)

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

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Related Devices (Code: QAZ)

DEN17004623andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)23AndMe, Inc. K182784MUTYH-Associated Polyposis (MAP)23AndMe, Inc. K22359723andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)23AndMe, Inc.

Official Source

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