| Device |
interoperable automated glycemic controller |
| Regulation Description |
Interoperable automated glycemic controller. |
| Definition |
An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control. |
| Physical State |
This is a software device used to control a compatible insulin pump based on inputs from compatible glucose monitor. |
| Technical Method |
Works interoperably with a integrated continuous glucose monitor to measure glucose levels and increases or reduces insulin infusion from an alternate controller enabled insulin pump. |
| Target Area |
SASO |
| Regulation Medical Specialty |
Clinical Chemistry |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | QJI |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
862.1356
|
|---|
| 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
|
|---|
| Third Party Review |
Not Third Party Eligible |
