ii
to acetoacetate. The magnitude of electrical current resulting from this enzymatic
reaction is proportional to the amount of β-hydroxybutyrate present in the sample.
The Keto-Mojo
®
GK+ Blood Glucose and β-Ketone Dual Monitoring System is
intended to quantitatively measure the glucose concentration and/or β-ketone
(beta-hydroxybutyrate) concentration in fresh capillary whole blood samples drawn
from the fingertips. It is intended for use by persons 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 for
self-testing outside the body (in vitro diagnostic use) and should only be used by a
single person and should not be shared.
The meter 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, including for routine assisted testing or as
part pf glycemic control procedures. 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.
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