QDK

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

Product code

QDK

Device name

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

Device class

Class 2

21 CFR

21 CFR 862.1355

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification definition

An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.

Definition text from the FDA device classification database (U.S. federal government work, public domain).