30
VivaChek™ Blood Glucose and
β-Ketone meter result.
The percent (and number) of
meter results that match true
blood β-ketone level within x%
25.0%
(2/8)
75.0%
(6/8)
100.0%
(8/8)
100.0%
(8/8)
For Blood β-Ketone Concentration <1.5 mmol/L
Difference range between the true
blood β-ketone level and the
VivaChek™ Blood Glucose and
β-Ketone meter result.
Within ±0.075
mmol/L
Within ±0.150
mmol/L
Within ±0.225
mmol/L
Within ±0.300
mmol/L
The percent (and number) of
meter results that match true
blood β-ketone level within x%
64.4%
(65/101)
90.1%
(91/101)
98.0%
(99/101)
99.0%
(100/101)
Accuracy Results for Blood β-Ketone Concentration ≥1.5 mmol/L
Accurate Results
(Meter result is +/-20% of laboratory result)
8 out of 8 (100.0% of results)
More Accurate Results
(Meter result is +/-15% of laboratory result)
8 out of 8 (100.0% of results)
Most Accurate Results
(Meter result is +/-10% of laboratory result)
6 out of 8 (75.0% of results)
Accuracy Results for Blood β-Ketone Concentration <1.5 mmol/L
Accurate Results
(Meter result is +/-0.300 mmol/L of
laboratory result)
100 out of 101 (99.0% of results)
More Accurate Results
(Meter result is +/-0.225 mmol/L of
laboratory result)
99 out of 101 (98.0% of results)
Most Accurate Results
(Meter result is +/-0.150 mmol/L of
laboratory result)
91 out of 101 (90.1% of results)
