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The Iron method for the Dimension Vista ™ system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism. The IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the IRON method for the Dimension Vista TM system.

The Dimension Vista™ IRON Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension Vista ™ system for the quantitative determination of iron in serum and plasma. The Dimension Vista™ Iron Calibrator is an aqueous solution of iron wire dissolved in a dilute solution of HCl. The kit contains three glass screw top vials, 1.0 mL each, of the Calibrator A (1075 ug/dL).

The IRON method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure iron in human serum and plasma. Iron measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.

The Dimension® IRON Flex® reagent cartridge (DF85) is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight well cartridge for use on the Dade Behring Dimension® clinical chemistry system for the quantitative determination of iron in serum and plasma.

The Sentinel Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of Iron without deproteinization in human serum and plasma (heparin salts, only). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

The Iron 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. The Iron Liquid is a direct colorimetric in vitro diagnostic assay for the quantitative determination of iron without deproteinization in human serum and plasma (heparin salt, only). In a pH 4.0 buffer system, iron is released from transferin to which it is bound, and then quantitatively reduced to a ferrous state. The iron forms with Ferene-S a stable colored complex of which the color intensity is proportional to the amount of iron in the sample. Particular reaction conditions and a specific masking agent eliminate the interference from copper.

The Vitalab Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of total iron in serum and plasma. Iron results may be used for the diagnosis and treatment of diseases associated with iron metabolism such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

The Vitalab Iron Reagent Kit and the Vitalab Selectra Analyzer are used as a system for the quantitative determination of total iron in serum and plasma. Iron in the sample is specifically released from transferrin using an acidic buffer. The released iron is then reduced and reacts with a chromogenic indicator. The increase in absorbance at 578 nm is measured photometrically. The increase in absorbance at 578 nm is proportional to the iron concentration of the sample.

The ATAC Iron Reagent Kit, which contains both reagent and calibrator, is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total iron in serum. The ATAC TIBC Column Kit, which is marketed with generic labeling and an ATAC 8000 Application Sheet, is intended for use with the ATAC Iron Reagent Kit and other iron reagents for the quantitative determination of total iron binding capacity in serum. Total iron results are used for the diagnosis and treatment of diciency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, and characterized by pigmentation of the skin), and chronic renal disease. Total iron binding capacity measurements are used for the diagnosis and treatment of anemia. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC Iron Reagent measures total serum iron by stripping it from the transferrin in a low pH reagent buffer, oxidizing it to ferric ions and binding it with Ferrozine. The resulting increase in absorbance at 546 nm is proportional to the iron concentration in the sample. The ATAC TIBC Column Kit is used to pretreat serum specimens prior analysis. The iron in the saturating reagent ensures that all available iron binding sites in the serum specimen are saturated with iron. The filtrate is assayed with an iron reagent after removing the unbound iron form the sample mixture by passing it through an alumina column. The maximum amount of iron bound in the specimen is a measure of its transferrin concentration.

An iron (non-heme) test system is a device intended to measure iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis and chronic renal disease. For the quantitative determination of iron in serum and heparinized plasma. For IN VITRO diagnostic use.

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The "Wiener lab. Fer-Color AA" iron test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of iron (non-heme) in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, and hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

End point method. Serum iron is released from its specific carrier protein (transferrin) in a pH 4.5 acetate buffer, and in the presence of a reducing agent (ascorbic acid). Then it reacts with the color reagent, pyridyl bis-phenyl triazine sulfonate (ferrozine) producing a colored complex measured at 570 nm.

The Iron assay is used for the quantitation of iron in human serum on the ALCYON 300/300i Analyzer. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Iron is an in vitro diagnostic assay for the quantitative determination of iron in human serum. The Iron assay is a clinical chemistry assay which utilizes an acidic media to release ferric iron from the transferrin. The ferric iron is converted to the ferrous form by the action of hydroxylamine hydrochloride. The released ferrous iron reacts with FERENE® to produce a colored Iron-FERENE complex. The absorbance of the Iron-FERENE complex is measured at 600 nm and is proportional to the concentration of iron present in the sample. Thiourea and detergent are added to reduce copper interference and turbidity, respectively.

For the quantitative determination of iron in serum. For IN VITRO diagnostic use.

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IL Test™ Iron is intended for the quantitative in vitro diagnostic determination of iron in human serum and plasma using the ferene method on Instrumentation Laboratory's line of clinical chemistry systems. A total iron binding capacity (TIBC) determination can also be performed using IL Test™ Iron in conjunction with the IL Test™ TIBC Sample Preparation Kit.

IL Test™ Iron permits the quantitative in vitro diagnostic determination of iron in human serum and plasma using the ferene method on Instrumentation Laboratory's line of clinical chemistry instruments. Measurements of the levels of iron are used in the diagnosis and treatment of iron deficiency anemia, hemochromatosis and chronic renal disease. A total iron binding capacity (TIBC) determination can also be performed using IL Test™ Iron in conjunction with the IL Test™ TIBC Sample Preparation Kit.