Intended Use; Test Principle - ForaCare GD40 Manual Del Usuario

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 profession-
als in clinical settings as an aid in monitoring the effectiveness of
diabetes control. It is intended to be used for the quantitative mea-
surement of glucose (sugar) in fresh capillary whole blood samples
drawn from the fingertips. It should not be used for the diagnosis of or
screening for diabetes mellitus.
It should not be used for the diagnosis of or screening for diabetes, or
testing on neonates.

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 reac-
tion depends on the amount of glucose in the blood sample.
This system uses enzyme of FAD–dependent glucose dehydrogenase
(FAD-GDH) from E. coli.
9