SBA — Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate Class II
FDA product code SBA covers "Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate", a Class II medical device regulated under 21 CFR 862.1357. Submissions are reviewed by the Clinical Chemistry panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SBA
- Device Class
- Class II
- Regulation Number
- 862.1357
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- Yes
Definition
An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose 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. The dexamethasone acetate coating is intended to reduce inflammation at the sensor insertion site.