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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 the device name listed in this FDA 510(k) record. The listed applicant is 23AndMe, Inc.. It received FDA 510(k) clearance on 2023-08-31 under 510(k) 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. The listed applicant is 23AndMe, Inc.. The 510(k) number is K223597.

When did 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) receive FDA 510(k) clearance?

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

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

The FDA 510(k) record lists 23AndMe, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07764744Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic VariantsNOT_YET_RECRUITINGNCT06292299The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility StudyRECRUITINGNCT07288593INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity InterventionNOT_YET_RECRUITINGNCT07678112Medical Device for Sustained Remission in Rheumatoid Arthritis Treated With Biological TherapyRECRUITINGNCT07145632APP-based Medical Device for Education and Training of Inhalation TechniqueRECRUITING

Other records listing 23AndMe, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K22188523andMe Personal Genome Service (PGS) Pharmacogenetic ReportsK21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)K19349223andMe Personal Genome Service (PGS) Pharmacogenetic ReportsK182784MUTYH-Associated Polyposis (MAP)

Related Devices (Code: QAZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)23AndMe, Inc.K182784MUTYH-Associated Polyposis (MAP)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.

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