Lifescan OneTouch SS Xpress, Instructions For Use Manual, Page: 94 / 158

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
performed on the clinical data set from all 5 clinical study
sites to identify any potential safety issues with the use of
the OneTouch StatStrip system within each medical condi-
tion 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 the Clini-
cal Study Performance section.
Appendix