McKesson Consult - Intended Use of Consult Hemoglobin Testing System; Principles of the Consult Hemoglobin Testing Procedure

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INTENDED USE
The Consult
®
Hemoglobin Testing System is intended for the in vitro quantitative measurement of total
hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in K2EDTA or
lithium heparin tubes in point-of-care settings and in non-anticoagulated capillary whole blood and venous
whole blood drawn in K2-EDTA tubes in blood bank settings. The Consult
®
Hemoglobin Testing System
consists of the Consult
®
Hemoglobin analyzer and specifically designed disposable cuvettes, the Consult
®
Cuvettes. The Consult
®
Hemoglobin analyzer is only to be used with Consult
®
Hemoglobin Cuvettes.
• Caution: Federal law restricts this device for sale by or on the order of a physician or
other licensed practitioner (Rx only).
• CLIA Complexity for whole blood: Waived
Laboratories with a Certificate of Waiver must follow the manufacturer’s instructions for performing the test
or the test will no longer be considered CLIA waived.
PRINCIPLES OF THE PROCEDURE
Based on a photometric principle, the Consult
®
Hemoglobin Testing System utilizes a broad-spectrum,
multi-chromatic sensor with compensation for turbidity and scattering which measures the absorbance
of whole blood over a wide spectral range. The light path length through the cuvette cavity, in combination
with the Consult
®
Hemoglobin analyzer, determines the exactness of the hemoglobin measurement. The
cuvettes do not contain any reagent. The hemoglobin concentration is calculated from the measured
absorbency at multiple wavelengths.
The system is factory calibrated (and requires no further calibration) against the hemiglobincyanide (HiCN)
method, the international reference method for the determination of hemoglobin concentration in blood as
described in NCLLS H15-A3and ICSH standard 1995.
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CONSULT
®
HEMOGLOBIN TESTING SYSTEM USER MANUAL