Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
The Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems is a Class 2 clinical chemistry device that automatically measures glucose continuously or frequently, is factory calibrated to replace finger stick blood glucose testing for diabetes treatment decisions, transmits data to digitally connected devices, and is specifically not intended for use with automated insulin dosing systems. It requires 510(k) clearance and is regulated under 21 CFR 862.1355 within the Clinical Chemistry medical specialty. The product code is QLG. The device is not an implant and is not flagged as life-sustaining.
Research product code QLG in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QLG
- 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 for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K222280 | Bigfoot Unity® Diabetes Management System | Mar 01, 2023 | Substantially Equivalent | Bigfoot Biomedical, Inc. |
| K223537 | FreeStyle Libre 2 System, FreeStyle Libre 3 System | Feb 21, 2023 | Substantially Equivalent | Abbott Diabetes Care, Inc. |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | May 26, 2022 | Substantially Equivalent | Abbott Diabetes Care, Inc. |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | May 26, 2022 | Substantially Equivalent | Abbott Diabetes Care, Inc. |
| K210943 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Nov 22, 2021 | Substantially Equivalent | Abbott Diabetes Care, Inc. |
| K211102 | FreeStyle Libre 2 Flash Glucose Monitoring System | Aug 11, 2021 | Substantially Equivalent | Abbott Diabetes Care, Inc. |
| K201761 | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | Jul 30, 2021 | Substantially Equivalent | Abbott Diabetes Care, Inc. |
| K202145 | Bigfoot Unity Diabetes Management System | May 07, 2021 | Substantially Equivalent | Bigfoot Biomedical, Inc. |
| K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Jun 12, 2020 | Substantially Equivalent | Abbott Diabetes Care, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.