DeviceClearance

Product code QDL— Clinical Chemistry

Dexcom Pro Q Continuous Glucose Monitoring System

Classification name
Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
Device class
Class 2
Regulation
21 CFR 862.1355
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

FDA classification definition

“An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.”

— U.S. Food and Drug Administration, device classification record for product code QDL under 21 CFR 862.1355, via openFDA

Market context for product code QDL

FDA has cleared 1 device under product code QDL, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QDL

Recent clearances under product code QDL

Data sourced from openFDA. This site is unofficial and independent of the FDA.