| Device |
integrated continuous glucose ketone monitoring system, factory calibrated |
| Definition |
An integrated continuous glucose ketone monitoring system (iCGK) is intended to automatically measure glucose and/or ketones in bodily fluids continuously or frequently for a specified period of time. iCGK systems are designed to reliably and securely transmit glucose and/or ketone measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control or ketone fluctuation. |
| Physical State |
Glucose ketone sensor, a transmitter, and a primary receiver. The device contains software to calculate glucose and ketone values. |
| Technical Method |
A transcutaneous glucose ketone 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 and ketone levels for the management of diabetes. |
| Target Area |
Interstitial fluid in subcutaneous tissue under the skin |
| Regulation Medical Specialty |
Clinical Chemistry |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | SJD |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
862.1354
|
|---|
| 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 |
