Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
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 for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.