Product code QBJ

Device name

Integrated Continuous Glucose Monitoring System, Factory Calibrated

Medical specialty

Clinical Chemistry

Device class

2

Regulation number

862.1355

Review panel

CH

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose 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.

Source

FDA openFDA device classification dataset