Cleared Traditional

K223597 - 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223597 · 23AndMe, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
272d
Days
Class 2
Risk

K223597 is an FDA 510(k) clearance for the 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1.... Classified as Cancer Predisposition Risk Assessment System (product code QAZ), Class II - Special Controls.

Submitted by 23AndMe, Inc. (San Franciso, US). The FDA issued a Cleared decision on August 31, 2023 after a review of 272 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6090 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all 23AndMe, Inc. devices

Submission Details

510(k) Number K223597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 77d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QAZ Cancer Predisposition Risk Assessment System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.