OneTouch Select Plus Flex - System Accuracy; System Accuracy Results for Glucoseconcentrations <5.55 Mmol;L

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Detailed information about your system
9
System Accuracy
Diabetes experts have suggested that glucose meters
should agree within 0.83mmol/L of a laboratory
method when the glucose concentration is lower than
5.55mmol/L, and within 15% of a laboratory method
when the glucose concentration is 5.55mmol/L or higher.
Samples from 100 patients were tested using both the
OneTouchSelect Plus Flex™ System and the YSI 2300
Glucose Analyzer laboratory instrument.
System Accuracy Results for Glucose
Concentrations <5.55mmol/L
Percent (and number) of meter results that match the
laboratory test
Within
±0.28mmol/L
Within
±0.56mmol/L
Within
±0.83mmol/L
67.2%
(121/180)
93.3%
(168/180)
96.7%
(174/180)
Y
ellow= 5mm Red=7mm mar
g
in
PF3130451Rev1_OTSPF_OB_I_GB_en_zug_R2.indd 105 3/12/15 11:36 AM
Statement of Use: Verify status before each use
Effectivity Date: Mar 18 2015 Status: Current State: Released
Type: Project File Name: 3130451 Revision: 1