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The Sentinel UIBC Liquid (Unsaturated Iron Binding Capacity) assay is intended to measure the unsaturated iron-binding capacity in serum and plasma. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. CFR 862.1415

The Sentinel UIBC Liquid described in this 510(k) submission is composed of reagents and standard, packaged and distributed in the same kit. The device is intended to be sold as an in vitro test for professional use. Serum is added to an alkaline buffer/reductant solution containing a known concentration of iron to saturate the available binding sites on transferrin. The iron that remains free after transferrin saturation is reduced to a ferrous state and then complexed by Ferene-S to form a stable complex, of which the color intensity is measured at 580-600nm. UIBC is therefore determined by subtracting the quantity of unbound iron from the total added quantity.

The Wako L-type UIBC test is an in vitro diagnostic assay for the quantitative determination of iron in serum. Measurement of serum iron concentration, UIBC and total iron binding capacity (TIBC) are is largely of use in the diagnosis of iron deficiency anemia, hemochromatosis, chronic inflammatory disorders and malignancies.

The Wako L-type UIBC is a method utilizing bathophenanthroline as a chromogen. When a sample is mixed with the Buffer containing a known excess amount of iron, unsaturated transferrin in serum quantitatively associates with iron in the Buffer and is converted to a saturated state. The portion of iron which remains unassociated is assayed through color development with ascorbic acid and bathophenanthroline disulfonic acid disdoium salt. The unsaturated transferrin concentration in the sample can be determiend by calculating the decrement of iron in the Buffer.