NOVA BIOMEDICAL StatStrip 55848 - Page 76

A-10
StatStrip Glucose Hospital Meter
Table A-2 Arterial 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 #1 362/538 497/538 515/538 523/538 532/538 6/538
(67.3%) (92.4%) (95.7%) (97.2%) (98.9%) (1.1%)
Site #2 120/214 195/214 208/214 214/214 214/214 0/214
(56.1%) (91.1%) (97.2%) (100%) (100%) (0.0%)
Site #3 83/122 112/122 115/122 117/122 120/122 2/122
(68.0%) (91.8%) (94.3%) (95.9%) (98.4%) (1.6%)
Site #4 257/349 330/349 340/349 346/349 348/349 1/349
(73.6%) (94.6%) (97.4%) (99.1%) (99.7%) (0.3%)
Site #5 22/44 41/44 42/44 44/44 44/44 0/44
(50.0%) (93.2%) (95.5%) (100%) (100%) (0.0%)
Combined 844/1,267 1,175/1,267 1,220/1,267 1,244/1,267 1,258/1,267 9/1,267
All Sites (66.6%) (92.7%) (96.3%) (98.2%) (99.3%) (0.7%)
Table A-3 Venous Specimens
Analytical and System Accuracy Comparison: Glucose
concentrations < 75 mg/dL
Site Within
±5 mg/dL
Within
±10 mg/dL
Within
±12 mg/dL
Within
±15 mg/dL
Exceeds
±15 mg/dL
Site #1 17/20 20/20 20/20 20/20 0/20
(85.0%) (100%) (100%) (100%) (0.0%)
Site #2 51/59 57/59 58/59 59/59 0/59
(86.4%) (96.6%) (98.3%) (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 68/79 77/79 78/79 79/79 0/79
All Sites (86.1%) (97.5%) (98.7%) (100%) (0.0%)
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 10 9/13/18 8:29 AM