510(k) DEN250049
DEN250049 is an FDA 510(k) premarket notification submitted by Abbott Diabetes Care for the device "Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System". The FDA issued a decision of De Novo Granted on August 25, 2026. The device falls under product code SJD (Integrated Continuous Glucose Ketone Monitoring System), a Class II device regulated under 21 CFR 862.1354. Abbott Diabetes Care has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 25, 2026
- Date Received
- September 29, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Integrated Continuous Glucose Ketone Monitoring System
- Device Class
- Class II
- Regulation Number
- 862.1354
- Review Panel
- CH
- Submission Type
An integrated continuous glucose ketone monitoring system (iCGK) is intended to automatically measure glucose and ketones in bodily fluids continuously or frequently for a specified period of time. iCGK systems are designed to reliably and securely transmit glucose and ketone measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control or ketone fluctuation. When making therapeutic adjustments, ketone output should be used in conjunction with glucose levels, symptoms, and factors that may affect ketone levels such as eating patterns and exercise.