TELCARE
™
Blood Glucose Monitoring System
The TELCARE™ Blood Glucose Monitoring system is intended
for the quantitative measurement of glucose in fresh capillary
whole blood samples drawn from the fingertips, forearm, or
palm. It is intended for lay use by persons with diabetes to
aid in diabetes management. It is indicated for use at home
(over the counter [OTC]) and should be used only by a single
patient and should not be shared. Test results are plasma-
calibrated for easy comparison to clinical laboratory methods.
Testing is done outside the body (in vitro diagnostic use).
The TELCARE™ Blood Glucose Monitoring System consists
of the Telcare BGM™ Blood Glucose Meter, TELCARE™
Blood Glucose Test Strips, and TELCARE™ Glucose Control
Solutions. The TELCARE™ Blood Glucose Monitoring system
is not indicated for the diagnosis or screening of diabetes or
for neonatal use. Palm and forearm testing should be done
only during steady-state times when glucose is not changing
rapidly. The Telcare BGM™ Blood Glucose Meter uses cellular
data transmission to send test results to TELCARE™’s remote
database, Telserve, and to receive messages from Telserve. The
TELCARE™ Blood Glucose Monitoring System is not intended
to provide automated treatment guidance or decisions, nor is it
to be used as a substitute for professional healthcare judgment.
Intended Use
(i)
