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..
FDA 510(k) Cleared Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Devices (Product Code QLG)
About Product Code QLG - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code QLG since 2020, with 9 receiving FDA clearance (average review time: 223 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.
QLG devices are reviewed by the Chemistry panel. Browse all Chemistry devices →