PC24 SOP/ OP0274 & CL072 / Blood Glucose Monitoring (TEE2 Blood Glucose Monitors) / v1 / November 2020
Performance Characteristics
The performance of TEE2 Blood Glucose Monitoring System has
been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the TEE2 BGM System (Model
GM505KAB, GM505KBB) was assessed by comparing blood
glucose results obtained by patients with those obtained using
a YSI Model 2300 Glucose Analyser, a laboratory instrument. The
following results were obtained by diabetic patients at clinic
centres.
Slope
1.02
Y-intercept
-0.41 mmol/L
Correlation coefficient (r)
0.992
Number of sample
122
Range tested
2.2 ~ 32.1 mmol/L
Precision: The precision studies were performed in a laboratory
using TEE2 BGM Systems.
Within Run Precision
Blood avg.
2.3 mmol/L
SD = 0.1 mmol/L
Blood avg.
4.4 mmol/L
SD = 0.2 mmol/L
Blood avg.
7.2 mmol/L
CV = 2.6%
Blood avg.
11.2 mmol/L
CV = 3.1%
Blood avg.
19.4 mmol/L
CV = 2.7%
Total Precision
Control avg.
2.0 mmol/L
SD = 0.07 mmol/L
Control avg.
6.5 mmol/L
CV = 2.3%
Control avg.
17.9 mmol/L
CV = 2.4%
This study shows that there could be variation of up to 3.1%.
Accuracy results for glucose concentration < 4.2 mmol/L
Within ± 0.28 mmol/L
Within ± 0.56 mmol/L
Within ± 0.83 mmol/L
11/11 (100%)
11/11 (100%)
11/11 (100%)
Accuracy results for glucose concentration ≥ 4.2 mmol/L
Within ± 5%
Within ± 10%
Within ± 15%
Within ± 20%
47/111 (42%)
89/111 (80%)
109/111 (98%)
111/111 (100%)
