DEN240080 is an FDA 510(k) submission for the Biolinq Shine Autonomous Time-in-Range Microsensor. This device is classified as a Glucose Range Monitoring System (Class II - Special Controls, product code SFU).
Submitted by Biolinq Incorporated (San Diego, US). The FDA issued a Not Cleared (DENG) decision on September 23, 2025.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1359. A Glucose Range Monitoring System (grm) Is Intended To Automatically Measure Glucose In The Body And Provide Qualitative Or Semi-quantitative Information About Glucose Levels Or Trends Continuously Or Frequently. Grm Systems Are Intended To Support General User Awareness Of Glucose Ranges Related To Glycemic Control. Outputs From Grm Systems Do Not Represent Quantitative Glucose Concentration Values And Grm Systems Are Not Intended To Be Used For Acute Medical Decision-making, Such As Insulin Dosing Or Medication Adjustment..
| 510(k) Number | DEN240080 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 27, 2024 |
| Decision Date | September 23, 2025 |
| Days to Decision | 270 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | - |
| Product Code | SFU - Glucose Range Monitoring System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1359 |
| Definition | A Glucose Range Monitoring System (grm) Is Intended To Automatically Measure Glucose In The Body And Provide Qualitative Or Semi-quantitative Information About Glucose Levels Or Trends Continuously Or Frequently. Grm Systems Are Intended To Support General User Awareness Of Glucose Ranges Related To Glycemic Control. Outputs From Grm Systems Do Not Represent Quantitative Glucose Concentration Values And Grm Systems Are Not Intended To Be Used For Acute Medical Decision-making, Such As Insulin Dosing Or Medication Adjustment. |