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11 Appendix

301-7146 English Rev B 11/02/2011 Operator’s Manual NA 211

Chapter 11 – Appendix

Performance Characteristics

Analytical Performance

The system demonstrates an agreement > 95% within +/- 1 color block

with respect to results for the same specimens run on a competitive

instrument.

Analytes Report Ranges (Includes pH and Specific Gravity)

Parameter

Conventional

Units

S. I. Units Qualitative

Units

Bilirubin

Neg

2 mg/dL 34 µmol/L +

4 mg/dL 70 µmol/L ++

Urobilinogen

Neg Neg Neg

2.0 mg/dL 34 µmol/L +

4.0 mg/dL

70 µmol/L

Ketones

Negative

0.5

Trace

20 mg/dL 2 mmol/L +

80 mg/dL 8 mmol/L ++

Glucose

Neg Neg Neg

50 mg/dL 2.8 mmol/L +

150 mg/dL 8.3 mmol/L ++

≥ 500 mg/dL ≥ 28 mmol/L +++