Product code QAZ— Medical Genetics
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
- Classification name
- Cancer Predisposition Risk Assessment System
- Device class
- Class 2
- Regulation
- 21 CFR 866.6090
- Advisory panel
- Medical Genetics
- Total cleared
- 4
- First cleared
- Most recent
FDA classification 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 persons 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.”
Market context for product code QAZ
FDA has cleared devices under product code QAZ between 2018 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2022
- 2019
- 2018
Top applicants under product code QAZ
Recent clearances under product code QAZ
- K223597 — 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
- K211499 — 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
- K182784 — MUTYH-Associated Polyposis (MAP)
- DEN170046 — 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
Data sourced from openFDA. This site is unofficial and independent of the FDA.