Performance Characteristics - Prodigy AutoCode Manual Del Proprietário

Performance Characteristics

• Accuracy: > 95% of the individual glucose results
fell within ± 15 mg/dL (0.83 mmol/L) at glucose
concentration < 75 mg/dL (4.2 mmol/L) and within
± 20% at glucose concentration ≥ 75 mg/dL (4.2
mmol/L), compared with glucose analyzer YSI 2300.
Table 1 represents samples for glucose results lower
than (<) 75 mg/dL
Difference between
laboratory and Prodigy
AutoCode® meter
number (%) for Finger
Blood
number (%) for palm
blood
number (%) for forearm
blood
number (%) for upper
arm
number (%) for calf
blood
number (%) for Thigh
blood
AutoCode
®
Within ±5
mg/dL
9/14 (64%) 13/14 (93%) 14/14
5/14 (36%) 14/14
3/14 (21%) 13/14 (93%) 14/14
8/14 (57%) 14/14
6/14 (43%) 12/14 (86%) 14/14
4/14 (29%) 13/14 (93%) 14/14
Owner's Manual
Blood Glucose Meter
Within ±10
mg/dL
(100%)
(100%)
Within ±15
mg/dL
(100%)
14/14
(100%)
(100%)
14/14
(100%)
(100%)
(100%)
64