Cleared Traditional

K182784 - MUTYH-Associated Polyposis (MAP) (FDA 510(k) Clearance)

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

K182784 · 23AndMe, Inc. · Medical Genetics device
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Jan 2019
Decision
109d
Days
Class 2
Risk

K182784 is an FDA 510(k) clearance for the MUTYH-Associated Polyposis (MAP). 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 Cleared decision on January 18, 2019 after a review of 109 days - within the typical 510(k) review window.

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 K182784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2018
Decision Date January 18, 2019
Days to Decision 109 days
Submission Type Traditional
Review Panel Medical Genetics (MG)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
290d faster than avg
Panel avg: 399d · This submission: 109d
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.