Gmate VOICE - Alternate Site Accuracy (Fingertips); Alternate Site Accuracy (Upper Arm)

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GMATE® VOICE PERFORMANCE CHARACTERISTICS
Alternate site:
Alternate site test results were compared to glucose test results at YSI 2300 STAT.
Test results at FINGERTIPS were compared to test results at YSI 2300 STAT.
System accuracy result for glucose concentrations ≥ 75 mg/dL (4.2 mmol/L)
Test results at UPPER ARM were compared to test results at YSI 2300 STAT.
System accuracy result for glucose concentrations < 75 mg/dL ( 4.2 mmol/L )
67% ( 63/94 )
94% ( 88/94 )
100% ( 94/94 )
100% ( 94/94 )
84% (79/94)
97% (91/94)
100% (94/94)
100% (94/94)
88% ( 7/8 )
100% ( 8/8 )
100% ( 8/8 )
100% (8/8)
50% (4/8)
100% (8/8)
within ± 5%
within ± 10%
within ± 15%
within ± 20%
within ± 5%
within ± 10%
within ± 15%
within ± 20%
within ± 5 mg/dL ( 0.28 mmol/L )
within ± 10 mg/dL ( 0.56 mmol/L )
within ± 15 mg/dL ( 0.83 mmol/L )
within ± 5 mg/dL ( 0.28 mmol/L )
within ± 10 mg/dL ( 0.56 mmol/L )
within ± 15 mg/dL ( 0.83 mmol/L )
System accuracy result for glucose concentrations ≥ 75 mg/dL ( 4.2 mmol/L )
System accuracy result for glucose concentrations < 75 mg/dL ( 4.2 mmol/L )