# DEN250049: Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System

- Pathway: De Novo (Direct)
- Applicant: Abbott Diabetes Care
- Decided: Aug 25, 2026 after 330 days
- Product code: SJD ( Integrated Continuous Glucose Ketone Monitoring System)
- Device class: 2
- Regulation: 21 CFR 862.1354
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
Libre Duo 10 Day is a Continuous Dual Glucose Ketone Monitoring System indicated for the management of diabetes in persons age 2 years and older. It is intended to monitor glucose and ketone (beta-hydroxybutyrate) levels in real-time. The System also provides alarms, detects trends, tracks glucose and ketone patterns, and aids in the detection of episodes of hyperglycemia, hypoglycemia, and hyperketonemia, facilitating both acute and long-term therapy adjustments, and the system replaces blood glucose testing for diabetes treatment decisions, unless otherwise indicated. Interpretation of system readings should be based on the trends and sequential readings over time. 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. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

Source page: https://510kreport.com/device/DEN250049
Methodology: https://510kreport.com/methodology