FDA Product Code QBJ: Integrated Continuous Glucose Monitoring System, Factory Calibrated
Under FDA product code QBJ, integrated continuous glucose monitoring systems are cleared for the non-adjunctive management of diabetes — meaning dosing decisions can be made based on CGM readings alone.
These systems use a subcutaneous sensor that continuously measures interstitial glucose every few minutes and transmits data to a display device or smartphone. Integrated systems are cleared to replace fingerstick testing for treatment decisions, including insulin dosing.
QBJ devices are Class II medical devices, regulated under 21 CFR 862.1355 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Dexcom, Inc. and Abbott Diabetes Care, Inc..
List of Integrated Continuous Glucose Monitoring System, Factory Calibrated 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 devices (product code QBJ). 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 →