Not Cleared Direct

DEN170046 - 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) (FDA 510(k) Clearance)

Class II Pathology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170046 · 23AndMe, Inc. · Pathology device
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Mar 2018
Decision
182d
Days
Class 2
Risk

DEN170046 is an FDA 510(k) submission (not cleared) for the 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). Classified as Cancer Predisposition Risk Assessment System (product code QAZ), Class II - Special Controls.

Submitted by 23AndMe, Inc. (Mountain View, US). The FDA issued a Not Cleared (DENG) decision on March 6, 2018 after a review of 182 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Pathology review framework.

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Submission Details

510(k) Number DEN170046 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 05, 2017
Decision Date March 06, 2018
Days to Decision 182 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 77d · This submission: 182d
Pathway characteristics

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.