Palmdoc I - Precision; Intermediate Precision; Repeatability; Performance Characteristics

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13. Performance characteristics
Precision
Standard deviation (SD) for each glucose
concentration < 5.55 mmol/L and coefcient of
variation (CV) for each glucose concentration
≥ 5.55 mmol/L) is ≤ 0.278 mmol/L and ≤ 5.0%,
respectively.
Intermediate precision
Control Solution Level
(mmol/L)
Low
(1.7~2.8)
Normal
(5.3~8.0)
High
(15.6~23.3)
Pooled Mean (mmol/L) 2.5 5.6 19.6
SD 3.0 3.0 8.1
CV (%) - 3.0% 2.3%
Repeatability
Blood Glucose
(mmol/L)
1.7~
2.8
2.9~
6.1
6.2~
8.3
8.4~
13.9
14.0~
22.2
Pooled Mean
(mmol/L)
2.2 4.6 7.2 11.2 18.0
SD 2.6 3.7 5.1 6.6 8.4
CV (%) 6.5% 4.5% 3.9% 3.3% 2.6%
System Accuracy
System accuracy results for glucose
concentration <5.6 mmol/L
Within ±0.28
mmol/L
Within ±0.56
mmol/L
Within ±0.83
mmol/L
114/180 (63.3%) 172/180 (95.6%) 180/180 (100%)
System accuracy results for glucose
concentration ≥ 5.6 mmol/L
Within ±5% Within ±10% Within ±15%
215/420 (51.2%) 336/420 (80.0%) 408/420 (97.1%)
13. Performance characteristics