QLG

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Product code

QLG

Device name

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Device class

Class 2

21 CFR

21 CFR 862.1355

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

9 (all years; only the last 3 years are listed here)

FDA classification definition

An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.

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