FDA Product Code QLG: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
FDA product code QLG covers factory-calibrated integrated continuous glucose monitoring systems that do not require fingerstick calibration.
These CGM systems use a factory calibration algorithm to eliminate the need for routine fingerstick blood glucose measurements to calibrate the sensor. They continuously measure interstitial glucose and transmit readings to a display device, simplifying diabetes management and improving adherence.
QLG devices are Class II medical devices, regulated under 21 CFR 862.1355 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Abbott Diabetes Care, Inc..
List of Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems devices (product code QLG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →