Lifescan OneTouch SS Xpress Instructions For Use Manual page 95

Appendix
Clinical Study Performance section.
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 OneTouch 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 Medical Condition Analysis Summary
Tables section.
A separate analysis was performed on all patient glucose
results <70mg/dL to identify any potential safety issues with
the use of the OneTouch StatStrip system in the hypoglyce-
mic range within the intended use population.
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