Intended Use
The FORA 6 Connect Multi-Functional Monitoring System is intended
for use in the quantitative measurement of glucose and β-ketone
(beta-hydroxybutyrate) in fresh capillary whole blood from the finger.
It is intended for in vitro diagnostic use by people with diabetes mellitus
at home as an aid in monitoring the effectiveness of diabetes control
program. It is not intended for the diagnosis of or screening for diabetes
mellitus, and is not intended for use on neonates. It is intended to be
used by a single person and should not be shared.
Test Principle
Your system measures the amount of sugar (glucose) and β-ketone in
whole blood. The glucose and β-ketone testing are based on the
measurement of electrical current generated by the reaction of glucose
and β-ketone with the reagent of the strip. The meter measures the
current, calculates the blood glucose and β-ketone level, and displays
the result. The strength of the current produced by the reaction
depends on the amount of glucose and β-ketone in the blood sample.
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