K233655 is an FDA 510(k) clearance for the Lingo Glucose System. This device is classified as a Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter (Class II - Special Controls, product code SAF).
Submitted by Abbott (Alameda, US). The FDA issued a Cleared decision on May 29, 2024, 197 days after receiving the submission on November 14, 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 Monitoring 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 In Persons Who Are Not On Insulin And Do Not Have A Significant Risk Of Problematic Hypoglycemia. Icgm Systems For Non-intensive Glucose Monitoring 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. Device Output Should Not Be Used To Make Treatment Decisions Without Consulting With A Qualified Healthcare Professional..
| 510(k) Number | K233655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2023 |
| Decision Date | May 29, 2024 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | SAF - Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, 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 Monitoring 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 In Persons Who Are Not On Insulin And Do Not Have A Significant Risk Of Problematic Hypoglycemia. Icgm Systems For Non-intensive Glucose Monitoring 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. Device Output Should Not Be Used To Make Treatment Decisions Without Consulting With A Qualified Healthcare Professional. |