25/65
10. FORA COMFORT check Blood Glucose Test Strip
ACS043
Accuracy
The table below displays how often FORA G40 achieves this target. The chart is
based on a study carried out on 160 patients (each patient was tested six times
which had 960 test results) to see how well FORA G40 performed compared to
YSI-2300 reference method results.
Table 1 Accuracy results for glucose concentration < 100 mg/dL (5.55 mmol/L)
Within ±5 mg/dL
(Within ±0.28mmol/L)
Within ±10 mg/dL
(Within ±0.55mmol/L)
Within ±15 mg/dL*
(Within ± 0.83 mmol/L)
60.6% (181/294)
90.1% (265/294)
100% (294/294)
Table 2 Accuracy results for glucose concentration
≧
100 mg/dL (5.55 mmol/L)
Within ±5 %
Within ±10 %
Within ±15 %*
49.7% (331/666)
81.7% (544/666)
96.4% (642/666)
Table 3 Accuracy results for glucose concentrations between 32.4mg/dL
(1.80mmol/L ) to 532.0mg/dL (29.56mmol/L)
Within ±15 mg/dL or ±15%
(Within ±0.83 mmol/L or ±15%)
97.5% (936/960)
Note:
*According to the accuracy criteria of EN ISO 15197: 2015, 95% of all
differences in glucose values (i.e., YSI-2300 reference values minus glucose
values of FORA G40) should be within ±15 mg/dL (0.83 mmol/L) for glucose
concentration < 100 mg/dL (5.55 mmol/L), and within ±15% for glucose
concentration ≥ 100 mg/dL (5.55 mmol/L). When Test Strips results are compared
to the reference values, difference values below 100 mg/dL (5.55 mmol/L) are
expressed in mg/dL or mmol/L, while those above 100 mg/dL (5.55 mmol/L) in
percentage.
User performance
160 subjects tested on the fingertip and the alternative sites, the palm, the
forearm and the upper arm. The tables show how well FORA G40 performed
compared to YSI-2300 reference method results.
Table 1 Difference distribution for glucose concentration < 100 mg/dL (5.55
mmol/L)
