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..
FDA 510(k) Cleared Integrated Continuous Glucose Monitoring System, Factory Calibrated Devices (Product Code QBJ)
About Product Code QBJ - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code QBJ since 2018, with 16 receiving FDA clearance (average review time: 133 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 9 in the prior period.
FDA Review Time
Recent submissions under QBJ have taken an average of 94 days to reach a decision - down from 141 days historically, suggesting improved FDA processing for this classification.
QBJ devices are reviewed by the Chemistry panel. Browse all Chemistry devices →