Cleared Traditional

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

K223597 · 23AndMe, Inc. · Pathology
Aug 2023
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K223597 is an FDA 510(k) clearance for the 23andMe? Personal Genome Service? (PGS?) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants), a Cancer Predisposition Risk Assessment System (Class II — Special Controls, product code QAZ), submitted by 23AndMe, Inc. (South San Francisco, US). The FDA issued a Cleared decision on August 31, 2023, 272 days after receiving the submission on December 2, 2022. This device falls under the Pathology review panel. Regulated under 21 CFR 866.6090.

Submission Details

510(k) Number K223597 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2022
Decision Date August 31, 2023
Days to Decision 272 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code QAZ — Cancer Predisposition Risk Assessment System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6090
Definition A Qualitative In Vitro Molecular Diagnostic System Used For The Detection Of Select Variants In Specified Cancer-related Genes. The Device Is Intended To Be Used On Genomic Dna Isolated From Human Specimens Collected By The User. The Results Of The Test Provide Users With A Genetic Health Risk Assessment For Developing Certain Cancers. The Test May Not Include All Variants Associated With A Predisposition Of Developing Cancer And Is Not Intended To Describe A Person?s Overall Risk Of Developing Any Type Of Cancer Nor To Aid In Determination Of Treatment Or Act As A Substitute For Recommended Cancer Screenings Or Appropriate Follow-up. The Device Is For Over-the-counter Use.