QAZ

Cancer Predisposition Risk Assessment System

Product code: QAZ
Device name: Cancer Predisposition Risk Assessment System
Device class: Class 2
21 CFR: 21 CFR 866.6090
Medical specialty: Medical Genetics
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 4 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QAZ

Classification and pathway per current FDA publications. Data from openFDA (CC0).