5
Intended Use
The GLUCOCARD Expression 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. Testing
is done outside the body (In Vitro diagnostic use). The meter includes
voice functionality to assist visually impaired users. It is indicated for lay
use by people with diabetes, as an aid to monitoring levels in Diabetes
Mellitus and should only be used by a single patient and it should not be
shared. It is not indicated for the diagnosis or screening of diabetes or for
neonatal use.