Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically and continuously or frequently measure glucose in bodily fluids for managing glycemic control, transmitting data to digitally connected devices including automated insulin dosing systems; the dexamethasone acetate coating is specifically included to reduce inflammation at the sensor insertion site. It is classified as FDA Class II (510(k) required) under regulation 862.1357 in the Clinical Chemistry specialty, with product code SBA. The device is flagged as an implant due to the subcutaneous sensor, but does not support life-sustaining functions.
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Basic Information
- Product Code
- SBA
- Device Class
- FDA class 2
- Regulation Number
- 862.1357
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.