Product code SJD— Clinical Chemistry
Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System
- Classification name
- Integrated Continuous Glucose Ketone Monitoring System
- Device class
- Class 2
- Regulation
- 21 CFR 862.1354
- Advisory panel
- Clinical Chemistry
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code SJD
FDA has cleared device under product code SJD, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SJD
Recent clearances under product code SJD
Data sourced from openFDA. This site is unofficial and independent of the FDA.