510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K223597Substantially Equivalent

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

23AndMe, Inc., San Franciso CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223597 is the FDA 510(k) clearance record for 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants), a class II device, cleared for 23AndMe, Inc. on under FDA product code QAZ (Cancer Predisposition Risk Assessment System). FDA's definition for product code QAZ reads: "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...". FDA records list 9 510(k) clearances for 23AndMe, Inc., from to . As of , FDA records show no recalls naming K223597.

Clearance record

Decision date
Received
(272 days to decision)
Product code
QAZ Cancer Predisposition Risk Assessment System
Regulation
21 CFR 866.6090
Device class
Class II
Review panel
Medical Genetics
Applicant
23AndMe, Inc. 349 Oyster Pt. Blvd., San Franciso CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QAZ

Trailing 12 months

FDA records hold no clearances under product code QAZ in the trailing twelve months.

FDA records show no clearances under product code QAZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QAZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260