Operator’s Manual – OPTI CCA-TS2 pH-B-3
ANALYTES pH (Dry Sensor)
Chemical Interferent
Concentration
pH Level Interference
Methylene Blue 0.125 mM
7.170 NO
7.520 0.033
Sodium Chloride 20 mM
7.170 NO
7.520 NO
The following samples were identiîš¿ed as interfering with the dry pH sensor in the interference study
performed for the OPTI LION 510(k) submission.
Interferent Test Level Change
Sodium Bisulphate 11.5mM -0.16
Phenylacetic Acid 10.0mM -0.12
Methylene Blue 25mg/dL Unstable
Fluorescein 25mg/dL Unstable
Reproducibility
Controls
Within-run precision (S
wr
) and Total Precision (S
T
), were determined from 2 runs per day with 2
replicates per run over a period of 20 days following the CLSI guideline EP5-A2. Typical results for 3
different control levels are shown below:
Dry pH OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3
Days Run 20 20 20
Total Average 7.168 7.418 7.632
Within Run St. Dev. (S
wr
) 0.011 0.008 0.007
Within Run % CV 0.2% 0.1% 0.1%
Total Precision St. Dev. (S
T
) 0.015 0.011 0.011
Total % CV 0.2% 0.1% 0.1%
Whole Blood
Within-run precision in whole blood samples was evaluated at 3 different concentrations on the OPTI
CCA-TS2. The table below shows the Averages, Standard Deviations and % CV calculated from 10
samples for each level.
Dry pH Whole Blood
Level 1 Level 2 Level 3
Average 7.174 7.352 7.558
St. Dev 0.011 0.019 0.012
%CV 0.16% 0.26% 0.17%
n 10 10 10
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