1. Intended Use
The DiaSpect Tm system is intended for the in vitro quantitative measurement of
total hemoglobin in non-anticoagulated capillary whole blood and venous whole
blood drawn in K2-EDTA 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 DiaSpect Tm system consists of the
DiaSpect Tm analyzer and specifically designed disposable cuvettes. The DiaSpect
Tm analyzer is only to be used with DiaSpect Tm 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.
2. Principles of the Procedure
Based on a photometric principle, the DiaSpect Tm 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 DiaSpect Tm
analyzer, determines the exactness of the hemoglobin measurement. The
hemoglobin concentration is calculated from the measured absorbance at multiple
wavelengths.
The cuvettes do not contain any reagent. The system is calibrated against the
hemoglobincyanide (HiCN) method, the international reference method for the
determination of hemoglobin concentration in blood as described in NCCLS/CLSI
H15-A3 and ICSH standard 1995.
1,2
The DiaSpect Tm analyzer is factory calibrated and requires no further calibration.
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