Cleared Traditional

K223597 - 23andMe Personal Genome Service (PGS) G...

K223597 is an FDA 510(k) clearance for 23andMe Personal Genome Service (PGS) G..., manufactured by 23AndMe, Inc.. The device is a Class 2 Pathology device with product code QAZ cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K223597 · 23AndMe, Inc. · Pathology device
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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.

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FDA 510(k) Submission Details - K223597

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.

QAZ Device Classification - Class 2, Special Controls

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.