Gmate VOICE - Alternate Site Accuracy (Thigh); Alternate Site Accuracy (Calf)

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GMATE® VOICE PERFORMANCE CHARACTERISTICS
Test results at THIGH were compared to test results at YSI 2300 STAT.
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)
Test results at CALF were compared to test results at YSI 2300 STAT.
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)
76% (71/94)
98% (92/94)
100% (94/94)
100% (94/94)
75% (6/8)
88% (7/8)
100% (8/8)
63% (59/94)
93% (87/94)
98% (92/94)
100% (94/94)
100% (8/8)
38% (3/8)
100% (8/8)
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%
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 )