Cleared Traditional

MUTYH-Associated Polyposis (MAP)

K182784 · 23AndMe, Inc. · Medical Genetics

Jan 2019

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K182784 is an FDA 510(k) clearance for the MUTYH-Associated Polyposis (MAP), a Cancer Predisposition Risk Assessment System (Class II — Special Controls, product code QAZ), submitted by 23AndMe, Inc. (Mountain View, US). The FDA issued a Cleared decision on January 18, 2019, 109 days after receiving the submission on October 1, 2018. This device falls under the Medical Genetics review panel. Regulated under 21 CFR 866.6090.

Submission Details

510(k) Number	K182784 FDA.gov
FDA Decision	Cleared 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

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.