55
13.
Performance characteristics
System accuracy results for glucose
concentration between 2.23 mmol/L and 28.17
mmol/L
Within±15 mg/dL
(0.83 mmol/L) or ±15%
588/600 (98.0%)
The PalmDoc I Blood Glucose Monitoring
System meets the requirements for System
Accuracy as stated in ISO 15197:2013.
User Performance
A study evaluating glucose values from
fingertip, palm, forearm, upper arm, calf, and
thigh capillary blood samples obtained by 100
lay persons showed the following results.
100% within ± 15 mg/dL (± 0.83 mmol/L)
of the medical laboratory values at glucose
concentrations below 100 mg/dL (5.55
mmol/L), and
≥
95% within ±15 % of
the medical laboratory values at glucose
concentrations at or above 100 mg/dL (5.55
mmol/L).
The study shows that the PalmDoc I compares
well with the laboratory method.
