SJD — Integrated Continuous Glucose Ketone Monitoring System Class II
FDA product code SJD covers "Integrated Continuous Glucose Ketone Monitoring System", a Class II medical device regulated under 21 CFR 862.1354. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SJD
- Device Class
- Class II
- Regulation Number
- 862.1354
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250049 | abbott diabetes care | Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System | August 25, 2026 |