FDA product code · Pathology

Cancer Predisposition Risk Assessment System

Name: FDA decisions, review times, recalls and adverse event reports for product code QAZ
Creator: 510(k) Report

QAZClass II21 CFR 866.6090510(k) required4 decisions since 20180 recalls

4 FDA decisions since 2018. 510(k) reviews decided 2021–2025 took a median of 255 days (half between 246 and 263). No recall names this code. The most-cited predicate is DEN170046, named by 3 later devices.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, pathology panel

Twenty years of QAZ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QAZ

1in 2023

2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QAZ

Too few QAZ 510(k)s in any year since 2007 to give a median.

Recalls per year · QAZ

No recall names QAZ since 2007.

Adverse event reports per year · QAZ

1in 2024

2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code QAZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	0
2022	1	—	1
2023	1	—	0
2024	0	—	1
2025	0	—	0
2026	0	—	—

FIG. 1 — QAZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QAZ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Cancer Predisposition Risk Assessment System

Which predicates do QAZ devices cite most?

Which QAZ devices have the deepest lineage?

What has FDA decided in QAZ lately?