10
Intended Use
Rosie RealTime blood glucose monitoring system is intended for use
outside the body (
in vitro
diagnostic use) by professionals for multiple-
patient use in professional healthcare 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. It is intended for use by professionals testing with capillary or
venous samples.
It should not be used for the diagnosis of or screening for diabetes, or
testing on newborns.
The system is only used with single-use, auto-disabling lancing devices.
It can only be used with Rosie RealTime test strips and Rosie RealTime
glucose control solutions.
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.
This system uses enzyme of Glucose Dehydrogenase (GDH) from
E. coli.
