A-8
StatStrip Glucose Hospital Meter
The StatStrip system performed consistently independent of
theinstitution,withoutsignicantclinicalinterferencefrom
drugs, ventilation (O
2
), endogenous substances, hematocrit,
medical condition, medical unit, or patient condition.
All arterial and venous patient specimens were analyzed
rstontheStatStripsystemandthenspundownwithin15
minutes to obtain a fresh plasma specimen and measured
on the central laboratory method.
Evaluation and Analysis
Nova Biomedical applied a number of clinical assessment
methods to demonstrate the performance of the StatStrip
versus central laboratory reference glucose methods. Each
of the assessment methods demonstrated that StatStrip
demonstrates acceptable clinical performance with both
Health Care Professionals (HCP’s) and POC operators
within the intended use population. A listing of the clinical
assessment methods used to evaluate the clinical data is
found below.
A detailed Medical Condition analysis (based upon World
Health Organization medical condition categories) was
performedontheclinicaldatasetfromallve(5)clinical
study sites to identify any potential safety issues with the
use of the StatStrip system within each medical condition
subpopulation. Based upon clinical chart review, paired
glucose results for each study participant within a medical
condition category were reviewed. Frequency distribution
tables for each Medical Condition are presented in Section
A.7.1.
A detailed Parent Drug Class (based upon U.S. Pharmaco-
peia) analysis was performed on the clinical dataset from all
5 clinical study sites to identify any potential safety issues
with the use of the StatStrip system within the intended
use population. Based upon clinical chart review, paired
glucose results for each study participant on one or more
drugs within a parent drug class were reviewed. Frequency
distribution tables for each Parent Drug class are presented
in section A.7.2.
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 8 9/13/18 8:29 AM
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