Lifescan OneTouch SS Xpress, Instructions For Use Manual

Page: 93 / 158

The OneTouch StatStrip system performed consistently
independent of the institution, without significant clini-
cal interference from drugs, ventilation (O
2
), endogenous
substances, hematocrit, medical condition, medical unit, or
patient condition.
All arterial and venous patient specimens were analyzed
first on the OneTouch StatStrip system and then spun down
within 15 minutes to obtain a fresh plasma specimen and
measured on the central laboratory method.
Evaluation and Analysis
A number of clinical assessment methods were applied
to demonstrate the performance of OneTouch StatStrip
versus central laboratory reference glucose methods. Each
of the assessment methods demonstrated that OneTouch
StatStrip demonstrates acceptable clinical performance with
Appendix