FDA Product Code SBH: 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 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.
Leading manufacturers include Abbott Diabetes Care.
FDA 510(k) Cleared Integrated Continuous Glucose Monitor For Non-intensive Glucose Management, Over-the-counter Devices (Product Code SBH)
About Product Code SBH - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SBH since 2024, with 1 receiving FDA clearance (average review time: 184 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SBH devices are reviewed by the Chemistry panel. Browse all Chemistry devices →