K233861 is an FDA 510(k) clearance for the Libre Rio Continuous Glucose Monitoring System. This device is classified as a Integrated Continuous Glucose Monitor For Non-intensive Glucose Management, Over-the-counter (Class II - Special Controls, product code SBH).
Submitted by Abbott Diabetes Care (Alameda, US). The FDA issued a Cleared decision on June 7, 2024, 184 days after receiving the submission on December 6, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1355. 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) Number | K233861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2023 |
| Decision Date | June 07, 2024 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | SBH - Integrated Continuous Glucose Monitor For Non-intensive Glucose Management, Over-the-counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1355 |
| 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. |