ForaCare FORA 6 Plus - Q3. What Is the Safety Information in Foras Blood Glucose Monitors

30/65
Table 1 Difference distribution for glucose concentration < 100 mg/dL (5.55
mmol/L)
Tested sites
Difference within
±5mg/dL
Difference within
±10mg/dL
Difference within
±15mg/dL
Fingertip
29/48 (64.0%)
43/48 (89.6%)
48/48 (100%)
Palm
27/42 (64.3%)
41/42 (97.6%)
42/42 (100%)
Forearm
31/42 (73.8%)
39/42 (90.5%)
42/42 (100%)
Upper arm
29/42 (69.0%)
38/42 (90.5%)
41/42 (97.6%)
Table 2 Difference distribution for glucose concentration ≥ 100 mg/dL (5.55
mmol/L)
Tested sites
Difference within
±5mg/dL
Difference within
±10mg/dL
Difference within
±15mg/dL
Fingertip
56/112 (50.0%)
87/112 (77.7%)
108/112 (96.4%)
Palm
49/118 (41.5%)
92/118 (78.0%)
118/118 (100%)
Forearm
43/118 (36.4%)
84/118 (71.2%)
115/118 (97.5%)
Upper arm
49/118 (41.5%)
87/118 (73.7%)
116/118 (98.3%)
Precision
In both intermediate precision and repeatability tests, the standard deviation (SD)
is within 5 mg/dL (0.28 mmol/L) for each glucose concentration < 100 mg/dL
(5.55 mmol/L) and the coefficient of variation (CV) is less than 5% for each
glucose concentration ≥ 100 mg/dL (5.55 mmol/L).
Q3: What is the safety information in FORA’s blood glucose monitors?
1. In FORA 6 meter, only blood glucose test strip and 3 in 1 test strip (BG/HCT/Hb)
can be used for the testing of newborns.
2. In FORA ADVANCE Pro and COMFORT Pro meter, the blood glucose test strip
and 3 in 1 test strip (BG/HCT/Hb) can be used for the testing of newborns.
3. The β-Ketone, total cholesterol and uric acid test strips shall NOT be used for the
testing of newborns.
4. Use this device ONLY for the intended use described in the manual.
5. For single use only.
6. Do NOT use accessories which are not specified by the manufacturer.