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Blood Glucose and β-Ketone Monitoring System
Dear VivaChek™ System User,
Thank you for choosing the VivaChek™ Blood Glucose and β-Ketone Monitoring
System! VivaChek™ Blood Glucose and β-Ketone Monitoring System is designed
for easy test of blood glucose/β-ketone and helps you keep them under control.
Read this User’s Manual carefully before you use your system. Please keep your
User’s Manual in a safe place, you may want to refer it in the future.
Thank you again for choosing the VivaChek™ System.
Intended Use and Principle
VivaChek™ Blood Glucose and β-Ketone Monitoring System is comprised of the
VivaChek™ Blood Glucose and β-Ketone Meter (VGM200), the VivaChek™ Blood
Glucose Test Strips (VGS01) and the VivaChek™ Blood β-Ketone Test Strips
(VKS01). Glucose measurement is based on electrochemical biosensor
technology using the enzyme Glucose Dehydrogenase to catalyze the formation of
gluconolactone from the oxidation of glucose whereby two electrons are produced.
The electrical current resulting from this enzymatic reaction is proportional to the
concentration of glucose in the sample and is measured by the meter. The meter is
calibrated to display the equivalent of plasma glucose values. Using the same
technology, β-ketone is converted by β-hydroxybutyrate dehydrogenase and the
magnitude of electrical current resulting from this enzymatic reaction is
proportional to the amount of β-hydroxybutyrate present in the sample.
The System is intended to quantitatively measure the glucose and β-ketone
concentration in fresh capillary whole blood samples drawn from the fingertips. It is
intended for self-testing outside the body (
in vitro
diagnostic use) by people with
diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not
intended for neonatal use or for the diagnosis of or screening for diabetes. This
system is intended to be used by a single person and should not be shared.
The System is not intended for use in healthcare or assisted-use settings such as
hospitals, physician offices, or long-term care facilities because it has not been
cleared by FDA for use in these settings. Use of this system on multiple patients
may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C
Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.
