PQF

Sensor, Glucose, Invasive, Non-Adjunctive

Product code

PQF

Device name

Sensor, Glucose, Invasive, Non-Adjunctive

Device class

Class 3

Medical specialty

Unknown

Marketing pathway

PMA

FDA classification definition

A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.

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