Clinical Study Performance - Lifescan OneTouch SS Xpress Instructions For Use Manual

Clinical Study Performance

Analytical and System Accuracy Comparison: Glucose con-
centrations < 75 mg/dL
Site Within
± 5 mg/dL
Site #1 64/82
(78.0%)
Site #2 79/93
(84.9%)
Site #3 1/1
(100%)
Site #4 19/25
(76.0%)
Appendix
Table A-1 Arterial Specimens
Within
±10mg/dL
75/82
(91.5%)
89/93
(95.7%)
1/1
(100%)
24/25
(96.0%)
Within Within
±12mg/dL ±15mg/dL
78/82 79/82
(95.1%) (96.3%)
91/93 92/93
(97.9%) (98.9%)
1/1 1/1
(100%) (100%)
25/25 25/25
(100%) (100%)
Exceeds
±15mg/dL
3/82
(3.7%)
1/93
(1.1%)
0/1
(0.0%)
0/25
(0.0%)
91