9
Intended Use
This system is intended for use outside the body (
in vitro
diagnostic
use) by people with diabetes at home and by health care profes-
sionals in clinical settings as an aid to monitoring the effectiveness
of diabetes control. It is intended to be used for the quantitative
measurement of glucose (sugar) in fresh whole blood samples (from
the finger, palm, forearm and upper arm).
It should not be used for the diagnosis of diabetes, or testing on
newborns.
Professionals may test with capillary and venous whole blood; home
use is limited to capillary whole blood testing.
Test Principle
Your system measures the amount of sugar (glucose) in whole
blood. The glucose testing is based on the measurement of electrical
current generated by the reaction of glucose with the reagent of the
strip. The meter measures the current, calculates the blood glucose
level, and displays the result. The strength of the current produced
by the reaction depends on the amount of glucose in the blood
sample.