Prodigy VOICE El Manual Del Propietario página 39

PRODIGY Voice® Blood Glucose Meter
2. The accuracy requirements for the blood
glucose monitoring system—meters and test
strips—as stated in ISO 15197 are:
Ninety-five percent (95%) of the individual
glucose results shall fall within ±15 mg/
dL (0.83 mmol/L) of the results of the
manufacturer's measurement procedure
at glucose concentrations < 75 mg/dL
(<4.2 mmol/L) and within ± 20% at glucose
concentrations ≥ 75 mg/dL ( ≥ 4.2 mmol/L).
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 < 50 mg/
dL to over 400 mg/dL measured using both
the manufacturer's meter and a clinical blood
glucose analyzer for comparison (reference
measurement).
Example
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 (from 55 mg/dL to 85 mg/dL).
Owner's Manual
PRODIGY Voice® Blood Glucose Meter
If meter A produces a measurement of 60 mg/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 systems. 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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Owner's Manual
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