Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose management is an over-the-counter device intended to automatically and continuously or frequently measure glucose in bodily fluids across clinically significant hypoglycemia and hyperglycemia ranges in persons not on insulin who do not have significant risk of problematic hypoglycemia, transmitting data to digitally connected devices (excluding insulin delivery controllers). It is classified as FDA Class II (510(k) required) under regulation 862.1355 in the Clinical Chemistry specialty, with product code SBH. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SBH
- Device Class
- FDA class 2
- Regulation Number
- 862.1355
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose management is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels across the range spanning clinically significant hypoglycemia and hyperglycemia levels in persons who are not on insulin and who do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose management are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices.
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 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.