Prodigy Diabetes Care, LLC www.prodigymeter.com
Prodigy Meter Owner’s Manual
42
How does this answer the FAQ?
The accuracy of the system is determined by a clinical study using
100 blood samples at interval glucose concentrations ranging from
< 50mg/dL to over 400 mg/dL.
Example 1
If the manufacturer’s reference measurement is 70 mg/dL this
means that the meter measurements are considered accurate if
they fall within ± 15 mg/dL of 70 mg/dL or in the range of 55 mg/
dL to 85 mg/dL
If meter A produces a measurement of 60mg/dL and meter B
measures 80 mg/dL, then both are in the acceptable range and
meet the accuracy requirement.
Each manufacturer has met the System Accuracy requirement
as part of its testing to be cleared for marketing. In the System
Accuracy testing a distribution of blood glucose readings will result
at the various glucose concentration levels for one manufacturer’s
system. This is the same for other manufacturer’s system.
Because of the range of acceptable readings for the accuracy
requirement, identical readings from two different meters on the
same blood sample may not happen.
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