
INTRODUCTION TO THE SYSTEM
ABOUT YOUR SYSTEM
Intended Use
The G-427B Blood Glucose Monitoring System is intended for use in the
quantitative measurement of glucose in capillary whole blood from the
finger. It is intended for use by people with diabetes mellitus at home as an
aid in monitoring the effectiveness of a diabetes control program. The
G-427B Blood Glucose Monitoring System intended to be used by a single
person and should not be shared.
The Blood Glucose Monitoring System 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. The Blood Glucose
Monitoring System is not to be used for the diagnosis of or screening of
diabetes, or for neonatal use.
The Test Strips are for use with the Blood Glucose Meter to quantitatively
measure glucose drawn from the fingertips.
The control solutions is intended for use with the system, to check that the
glucose meter and test strips are working properly and that you are doing
the test correctly. The solutions contain a known range of glucose, as
indicated on the strips vial bottles.
The system is intended for use outside the body (in vitro diagnostic use). It
is for single-patient use. It should be used only for testing glucose (sugar)
and only with fresh capillary whole blood samples taken from the finger.
The system is intended for use at home. It should not be used for the
diagnosis of diabetes or for the testing of newborns.
The System 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. Alternative site testing should be done
only during steady – state times (when glucose is not changing rapidly).
The G-427B blood glucose test strips are for use with the Blood Glucose
Meter to quantitatively measure glucose in fresh capillary whole blood
samples drawn from the fingertips.
The Taidoc control solutions is intended for use with the System, to check
that the glucose meter and test strips are working properly and that you are
doing the test correctly. These solutions contain a known range of glucose,
as indicated on the strips vial bottles.
This device is not intended for use in healthcare or assisted-use settings
such as hospitals, physician’s offices, or long-term care facilities
because it has not been determined to be safe and effective for use in
these settings, including for routine assisted testing or as part of
glycemic control procedures.
Use of this device on multiple patients may lead to transmission of
Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV),
Hepatitis B Virus (HBV), or other bloodborne pathogens.