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The HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter in a point-of-care setting such as a physician's office or hospital.

The HemoSite® Test System is a whole blood hemoglobin measurement device which consists of the Stat-Site® Meter (K911801), HemoSite® Test Card and {lot-specific} HemoSite® Test Module. The test employs dry reagent technology based on the azidemethemoglobin method. The blood sample is applied to one side of the HemoSite® Test Card and the color develops on the opposite side. The color produced is directly proportional to the concentration of hemoglobin in the sample and is read using light reflectance at a specific wavelength; the reflectance reading is performed and reported by the Stat-Site® meter.

The GDS® CholeSite® Test System is an in vitro diagnostic product for the quantitative determination of total cholesterol in whole blood. It is intended for the sole use with the GDS® Stat-Site® Meter.

This whole blood cholesterol test system consists of a CholeSite® Test Card, Test Card specific Test Module, and the hand-held Stat-Site® electronic reflectance photometer (Meter), The test methodology employs a dry reagent technology based on the cholesterel esterase method. When a drop of whole blood is applied to the top opening on the Test Card. The cholesters present in the patient's blood sample are hydrolyzed by cholesterol esterase. The free cholesterol is then oxidized by cholesterol oxidase, producing hydrogen peroxide, which substantially reacts with TOOS in a reaction catalyzed by peroxidase to produce a colored compound on the bottom of the Test Card. The Stat-Site® Meter, using reflectance at 660 nm, measures the color characteristics produced and converts the reflectance reading to a correlated cholesterol concentration value,

The GDS® HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter.

The HemoSite® Test Cards are dry-chemistry Test Cards that contain chemicals which react and produce color when hemoglobin is present. The Stat-Site® Meter is a reflectance colorimeter that reads color intensity. A Test Module is provided with each box of Test Cards. The Test-Module contains all current calibration information for the specific lot of reagent. The Test Module and Test Cards are coded to each other, and the Stat-Site® Meter will only operate if they are properly matched. HemoSite® Test Cards are dry reagent cards based on the azidemethemoglobin method. When a drop of whole blood is applied to the top of the Test Card, hemolysis occurs, with the release of hemoglobin. Sodium nitrite converts the hemoglobin to methemoglobin. Sodium azide converts methemoglobin to azidemethemoglobin to produce a brown color that is measured at 580 nm using the Stat-Site® Meter. The Stat-Site® Meter measures the color intensity and calculates the hemoglobin concentration.

The GDS® GlucoSite® Test System is a device for in vitro diagnostic use only. The GDS® GlucoSite® Test Card is ultagi looks are quantitative determination of glucose in whole blood. It is intended for use with the Stat-Site® Meter.

This whole blood glucose test system consists of a GlucoSite® Test Card, test card specific Test Module, and a portable, hand held Stat-Site® electronic reflectance photometer (Meter). The test method employs a dry reagent technology based on the glucose oxidase method and is specific for D-Glucose. When a drop of whole blood is applied to the top opening on the test card, the red blood cells are separated allowing only the plasma to pass through. Glucose oxidase catalyzes the oxidation of the glucose in the plasma to produce gluconic acid and hydrogen peroxide in the presence of atmospheric oxygen. The second enzyme peroxidase then catalyzes the reduction of hydrogen peroxide in presence of 4-amino-antipyrine with concomitant oxidation of the chromogen TOOS [N-ethyl-N-(2-hydroxy-3sulfopropyl)-m-toluidine] to produce a purple color that is measured at 660 nm. The intensity of color developed is correlated with the glucose concentration in the whole blood sample. The Stat-Site® Meter measures the reflectance of the color produced at 660 nm and converts the reflectance reading to corresponding plasma glucose values.