Cleared Traditional

K211499 - 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) (FDA 510(k) Clearance)

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

K211499 · 23AndMe, Inc. · Medical Genetics device
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Jan 2022
Decision
237d
Days
Class 2
Risk

K211499 is an FDA 510(k) clearance for the 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related). 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 January 6, 2022 after a review of 237 days - an extended review cycle.

This device falls under the Medical Genetics FDA review panel, regulated under 21 CFR 866.6090 - the FDA medical genetics 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 Medical Genetics review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K211499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2021
Decision Date January 06, 2022
Days to Decision 237 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d faster than avg
Panel avg: 399d · This submission: 237d
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 Medical Genetics devices follow this clearance model.