A-9
Appendix A
Instructions for Use Manual Appendix A
A separate analysis was performed on all patient glucose
results <70mg/dL to identify any potential safety issues with
the use of the StatStrip system in the hypoglycemic range
within the intended use population.
An analysis was performed to determine whether specimen
collection site (central or peripheral) or specimen type (ar-
terial or venous) has an impact on the performance of the
StatStrip system with the intended use population.
A.7.1 Clinical Study Performance
Table A-1 Arterial Specimens
Analytical and System Accuracy Comparison: Glucose
concentrations < 75 mg/dL
Site Within
± 5 mg/dL
Within
±10mg/dL
Within
±12mg/dL
Within
±15mg/dL
Exceeds
±15mg/dL
Site #1 64/82 75/82 78/82 79/82 3/82
(78.0%) (91.5%) (95.1%) (96.3%) (3.7%)
Site #2 79/93 89/93 91/93 92/93 1/93
(84.9%) (95.7%) (97.9%) (98.9%) (1.1%)
Site #3 1/1 1/1 1/1 1/1 0/1
(100%) (100%) (100%) (100%) (0.0%)
Site #4 19/25 24/25 25/25 25/25 0/25
(76.0%) (96.0%) (100%) (100%) (0.0%)
Site #5 0/0 0/0 0/0 0/0 0/0
(N/A) (N/A) (N/A) (N/A) (N/A)
Combined
163/201 189/201 195/201 197/201 4/201
All Sites (81.1%) (94.0%) (97.0%) (98.0%) (2.0%)
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 9 9/13/18 8:29 AM
To Next Page
Loading...
