QAZClass II

Cancer Predisposition Risk Assessment System

21 CFR 866.6090 / Medical Genetics

QAZ is the FDA product code for Cancer Predisposition Risk Assessment System, a class II device type, regulated under 21 CFR 866.6090. FDA's definition for this code 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 results of the test provide users with a genetic health risk assessment for...". As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 2023-08-31, and no recalls.

Classification record

Product code: QAZ
Device name: Cancer Predisposition Risk Assessment System
FDA 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.
Regulation: 21 CFR 866.6090
Device class: Class II
Review panel: Medical Genetics
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 4
Ingested recalls: 0

Clearances, product code QAZ

By decision year

4 clearances under product code QAZ with a decision year between 2018 and 2023, 2018 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QAZ by decision year
Year	Clearances
2018	1
2019	1
2022	1
2023	1

Applicants with the most clearances

Product code QAZ

Applicants holding the most 510(k) clearances under product code QAZ
Applicant	Clearances
23AndMe, Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

23andMe Genomics LLC

Recent clearances

Product code QAZ

Recent recalls

Product code QAZ

FDA records show no recalls under product code QAZ.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)