Intended Use
This system is intended for use outside the body (
in vitro
diagnostic use) by
people with diabetes at home and by healthcare professionals 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, upper arm, calf
and thigh). It should not be used for the diagnosis of diabetes, or testing on
newborns.
Professionals may test with capillary and venous blood sample; 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.
