| Device |
continuous glucose monitor, implanted, adjunctive use |
| Definition |
The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices. |
| Physical State |
This device comprises a subcutaneously implanted sensor containing the glucose specific biological sensor, an algorithm that converts sensor signals into glucose values, a display device that provides glucose values to the user, and a mechanism for transmitting data from the sensor to the display device. |
| Technical Method |
Signals from an implanted (subcutaneous) glucose specific biological sensor are algorithmically converted to glucose values which are provided to the user. |
| Target Area |
Interstitial fluid |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | QCD |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
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? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
