QAZ · Class II · 21 CFR 866.6090

FDA Product Code QAZ: Cancer Predisposition Risk Assessment System

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.

Leading manufacturers include 23AndMe, Inc..

4
Total
3
Cleared
200d
Avg days
2018
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Cancer Predisposition Risk Assessment System Devices (Product Code QAZ)

4 devices
1–4 of 4
Cleared Aug 31, 2023
23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
K223597
23AndMe, Inc.
Pathology · 272d
Cleared Jan 06, 2022
23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
K211499
23AndMe, Inc.
Medical Genetics · 237d
Cleared Jan 18, 2019
MUTYH-Associated Polyposis (MAP)
K182784
23AndMe, Inc.
Medical Genetics · 109d
Not Cleared Mar 06, 2018
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
DEN170046
23AndMe, Inc.
Pathology · 182d

About Product Code QAZ - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code QAZ since 2018, with 3 receiving FDA clearance (average review time: 200 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.