QAZ: Cancer Predisposition Risk Assessment System

Name: QAZ: Cancer Predisposition Risk Assessment System: FDA records
Creator: Arca

FDA product code QAZ. Class II, classified under 21 CFR 866.6090. What the classification flags say about Part 820 under the QMSR.

As of Oct 26, 2026, FDA product code QAZ (Cancer Predisposition Risk Assessment System) is Class II under 21 CFR 866.6090, reviewed through 510(k), with 4 linked 510(k), De Novo or BK numbers, 0 PMAs and 0 recall product records.

Classification

Product code: QAZ
Device name: Cancer Predisposition Risk Assessment System
Device class: Class II
Regulation: 21 CFR 866.6090
Review panel: Pathology
Premarket route: 510(k)
CGMP-exempt flag: No
Life-sustaining flag: No
Implant flag: No
Third-party review: Not a candidate
Summary malfunction reporting: Ineligible

FDA 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.

Data from openFDA as of 26 October 2026. Read the record on openFDA · FDA product code classification database

Part 820 requirements the flags point to

Part 820 rules for QAZ

CGMP exemptionClassification regulation, 21 CFR parts 862 to 892: Not flaggedFDA does not flag this product code as exempt.A manufacturer of a finished device of this type falls under part 820 (21 CFR 820.1(a)). Some classification regulations exempt only part of a generic device type, so read the regulation for your device.FDA: QMSR, CGMP exemptions · 21 CFR 820.35
Design and development, ISO 13485 clause 7.321 CFR 820.10(c): Rule names this classRule names Class II.21 CFR 820.10(c) requires manufacturers of class II and class III devices to comply with clause 7.3 and its subclauses.21 CFR 820.10
Traceability, ISO 13485 clause 7.5.9.221 CFR 820.10(d): Not flaggedFDA does not flag this code as life-supporting or life-sustaining.820.10(d) is not indicated by this flag.21 CFR 820.10 · 21 CFR 860.3 · QMSR final rule, comment 49
Complaint and record content21 CFR 820.35: Rule names this classApplies to every finished-device manufacturer, exempt or not.820.35 adds content to complaint records, servicing records and UDI recording on top of ISO 13485 clause 4.2.5. FDA says CGMP exemption does not lift these records.21 CFR 820.35 · FDA: QMSR, CGMP exemptions

These flags describe the classification of a product code. They are not a determination for a specific device or manufacturer. How a manufacturer meets 21 CFR 820.10 depends on its own device, its intended use and the full text of the rule.

Clearances and recalls on record

510(k), De Novo and BK numbers linked: 4 · Search these clearances
PMA numbers linked: 0
Recall product records: 0
Adverse event reports: Search MAUDE for QAZ

Recall records count products, and one recall event can add many. Counts show activity in a category. They do not measure its safety.

Search all 7,097 product codes, or read the guide to the Part 820 rules behind these flags.

Check your quality documents against Part 820

Arca puts your SOPs and design files in a library and compares them against the Part 820 requirements for your device in a grid, one row per document and one column per requirement, with each cell cited to its source.