| Device |
automated insulin dosing device system, bihormonal control |
| Definition |
A bihormonal automated insulin dosing system that achieves a target glucose level by automatically adjusting two glucose modulating therapies from an infusion pump. Hormone adjustments are based upon specified thresholds of measured glucose levels. |
| Physical State |
May include: Continuous glucose monitoring system, sensor, self monitoring blood glucose device, infusion pump, data management software |
| Technical Method |
Uses a glucose monitoring system to measure glucose levels and increases or reduces two glucose modulating therapies from an insulin pump |
| Target Area |
Not meant to act on a specific part of the body but works with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data management software |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | OZQ |
|---|
| Premarket Review |
Division of Chemistry and Toxicology Devices
(DCTD)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| 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 |
