User's Manual
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Intended Use
The Medisign MediKeto Plus 82 BT blood glucose and β-ketone monitoring system is intended to be used for
the quantitative measurement of glucose and β-ketone (beta-hydroxybutyrate) in fresh capillary whole blood
samples from the fingertips. Alternative site testing (palm and forearm) should be done only for glucose
measurement and during a steady-state times. Venous whole blood testing is limited to healthcare professionals
use only. It is intended for self-testing outside of the body (in vitro diagnostic use only) by people with diabetes
at home and healthcare professionals in a clinical setting as an aid to monitor the diabetes control. This system is
NOT for use in diagnosis of or screening for diabetes, or for neonatal use.
Test Principle
Glucose in the blood sample reacts with glucose dehydrogenase (FAD-GDH) on the test strip and a harmless
current is produced. The strength of these currents change with the amount of glucose in the blood sample and
the Medisign MediKeto Plus 82 BT blood glucose and β-ketone meter automatically interprets this reaction.
Glucose measurements are reported as plasma equivalents. Results that use a plasma equivalent method are
approximately 11% higher than those obtained with whole-blood equivalent test strips. This system is calibrated
with capillary blood samples with various glucose concentrations. The reference method is traceable by using
the NIST Standard Reference Materials (SRM). The method comparison was conducted by comparing the result
from the system of Glucose Oxidase method using an automatic analyzer.
β-Ketone in the blood sample reacts with beta-hydroxybutyrate dehydrogenase on the test strip respectively.
This reaction produces a harmless current and the Medisign MediKeto Plus 82 BT blood glucose and β-ketone
meter measures the current, calculates the β-ketone level and displays the result. The strength of the current is
dependent on the amount of β-ketone in the blood sample.