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Hemo Control is intended to be used for the quantitative determination of hemoglobin (Hb) concentrations in human blood. The Hemo Control Hemoglobin Microcuvettes are intended to be used with the Hemo Control photometer for the quantitative determination of hemoglobin (Hb) concentrations in human blood. For in-vitro diagnostic use only.

Hemo Control consists of the Hemo Control photometer / analyzer and the Hemo Control Hemoglobin Microcuvettes, its accessories and consumables (i.e. Control Solution Hb-con). The Hemo Control photometer / analyzer is a semi-automated, spectrophotometric instrument, which provides instant quantitative total hemoglobin results. Using the reagent filled microcuvette a small amount of arterial, venous or capillary blood is taken up by capillary action. The filled microcuvette is inserted into the Hemo Control photometer. The color produced by chemical reaction in the microcuvette is measured and the Hb value is displayed. The measurement accuracy of the Hemo Control Hemoglobin Measurement System can be verified by use of Hb-con control solution, a quality control material with pre-determined hemoglobin concentration. As a second quality control measurement, the control cuvette as a physical standard is used for a comfortable and cheap check of the device.

The Quo-Test Alc System is intended for the in vitro quantitative determination of glycated hemoglobin (%HbA1c) levels in venous whole blood samples (using K2EDTA and lithium heparin anticoagulants). Measurement of percent glycated hemoglobin (%HbA1c) is effective for monitoring long-term glycemic control in individuals previously diagnosed with diabetes mellitus. The Quo-Test A1c System is not intended for screening or diagnosis of diabetes or neonatal use. The device is intended for professional use in a clinical laboratory setting.

The Quo-Test Analyzer and A1c Test Kit (Quo-Test A1c System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from venous samples. The system contains a fluorimeter and two photometers to enable both fluorescent and photometric measurements to be made. The Quo-Test A1C Assay is calibrated by the manufacturer using European Reference Laboratory (ERL) calibrators. There are no user-serviceable parts in the analyzer. It has ports to support a printer and barcode scanner plus a USB port. It is powered by an AC/DC adapter plugged into a 100-240V AC outlet. The Quo-Test A1c Test Cartridge contains all the reagents, in a plastic cuvette, required to perform an HbA1c test on the Quo-Test Analyzer. The reagents consist of a lysing agent, buffer and a boronate fluorophore conjugate. A low level of sodium azide preservative is used to enhance the shelf life of the test cartridge. Each test cartridge is for single-use. The test cartridges are supplied in individual foil pouches and should be stored at 2 - 8°C.

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 K2EDTA or lithium heparin tubes. The DiaSpect Tm system consists of the DiaSpect Tm analyzer and specifically designed disposable cuvettes, the DiaSpect Tm Cuvettes. The device is intended for use in point-of-care settings. The DiaSpect Tm analyzer is only to be used with DiaSpect Tm Cuvettes.

The DiaSpect Tm system consists of an analyzer and cuvettes. The DiaSpect Tm analyzer is a spectrophotometric instrument for the total hemoglobin concentration in unaltered human blood. The DiaSpect Tm Cuvette is injection-molded of poly methyl methacrylate (PMMA) and contains a cavity of 10 uL volume. The cavity is empty.

The Hemo-Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The microcuvettes part number 3000-3012-0765 are indicated for use in the Hemo-Control Hemoglobin Measurement System and compatible measurement systems. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste. Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported. For In Vitro Diagnostic Use Only

The Hemo-Control Hemoglobin Measurement System is comprised of a Hemo-Control Hemoglobin Measurement Photometer and Hemo-Control Microcuvettes. The scope of this 510(k) is limited to a modification of the microcuvettes. The Hemo-Control Microcuvettes are single-use microcuvettes filled with dry reagents. A modified azide methemoglobin method is used. The use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled microcuvette is inserted into the Hemo-Control Hemoglobin Measurement Photometer, the color produced by the chemical reaction in the microcuvette is measured, and the Hb level is calculated and displayed. Light emitting diodes (LED's) are used as light sources with a photodiode to detect the light. The plastic microcuvette consists of a clear body with a cavity which takes up approximately 10 µL of blood which combines with the dry reagent chemistry. The optical distance between the microcuvette walls is fixed and permits photometric determination of the hemoglobin in undiluted blood samples using the Lambert-Beers Law. The microcuvette optical and chemical characteristics are unchanged by the modification. The Hemo Control Hemoglobin Measurement System with the microcuvette modification employs the identical fundamental scientific technology as the predicate device(s).