FDA product code QAZ: Cancer Predisposition Risk Assessment System
QAZ is the FDA product code for cancer predisposition risk assessment system. It is a Class II device, regulated under 21 CFR 866.6090 and reviewed by the Pathology panel. FDA has cleared 3 510(k) submissions under QAZ, 2 in the last five years. The average 510(k) review took 206 days (median 237). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cancer Predisposition Risk Assessment System |
| Device class | Class II |
| Regulation | 21 CFR 866.6090 |
| Review panel | PA — Pathology |
| Medical specialty | Medical Genetics |
| Premarket route | 510(k) |
510(k) clearances per year for QAZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 109 |
| 2022 | 1 | 237 |
| 2023 | 1 | 272 |
Compare with all 510(k) review times · Search every QAZ clearance
Top QAZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 23AndMe, Inc. | 3 | 2023-08-31 |
Most recent QAZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223597 | 23AndMe, Inc. | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | 2023-08-31 | 272 |
| K211499 | 23AndMe, Inc. | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | 2022-01-06 | 237 |
| K182784 | 23AndMe, Inc. | MUTYH-Associated Polyposis (MAP) | 2019-01-18 | 109 |
Recalls for QAZ devices
openFDA lists no recalls for product code QAZ.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0105 — Colorectal cancer screening; colonoscopy on individual at high risk
Frequently asked questions
What is FDA product code QAZ?
QAZ is the FDA product code for cancer predisposition risk assessment system. It is a Class II device, regulated under 21 CFR 866.6090 and reviewed by the Pathology panel.
What device class is QAZ?
Class II, regulation 21 CFR 866.6090. Typical premarket route: 510(k).
How long does a 510(k) take for product code QAZ?
Across 3 cleared submissions the average was 206 days from receipt to decision (median 237).
Which companies have the most QAZ clearances?
23AndMe, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code QAZ
- Run a recall and safety report across every QAZ manufacturer
- Watch product code QAZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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