| Device |
integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems |
| Regulation Description |
Integrated continuous glucose monitoring system. |
| 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. |
| Physical State |
Glucose sensor, a transmitter, and a primary receiver. The device contains software to calculate glucose values. |
| Technical Method |
A transcutaneous glucose sensor which is factory calibrated. The sensor is inserted at home by the end user and is used in conjunction with the associated transmitter and receiver to monitor glucose levels for the management of diabetes. |
| Target Area |
Diagnostics |
| Regulation Medical Specialty |
Clinical Chemistry |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | QLG |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
862.1355
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
