A-11
Appendix A
Instructions for Use Manual Appendix A
Table A-4 Venous Specimens
Analytical and System Accuracy Comparison: Glucose
concentrations > 75 mg/dL
Site Within
± 5%
Within
± 10%
Within
± 12.5%
Within
± 15%
Within
± 20%
Exceeds
± 20%
Site #1 77/112 108/112 111/112 111/112 112/112 0/112
(68.8%) (96.4%) (99.1%) (99.1%) (100%) (0.0%)
Site #2 84/127 116/127 123/127 127/127 127/127 0/127
(66.1%) (91.3%) (96.9%) (100%) (100%) (0.0%)
Site #5 10/29 22/29 26/29 29/29 29/29 0/29
(34.5%) (75.9%) (89.7%) (100%) (100%) (0.0%)
Combined
171/268 246/268 260/268 267/268 268/268 0/268
All Sites (63.8%) (91.8%) (97.0%) (99.6%) (100%) (0.0%)
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 11 9/13/18 8:29 AM
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