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The HemoCue® Hb 301 System is intended for quantitative determination of hemoglobin in primary care or blood donation settings. The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old in primary care setting. The HemoCue® Hb 301 System is intended to be used to determine the hemoglobin concentration for adults in blood donation setting. The HemoCue® Hb 301 System is for professional in vitro diagnostic use only.

The HemoCue® Hb 301 System provides a direct reading of the hemoglobin concentration in a sample using specially designed, single use microcuvette and an analyzer. The system can be used by non-laboratory personnel. The HemoCue® Hb 301 System consists of the following parts: - An analyzer supporting the following features: - Photometric determination of hemoglobin - Presentation of results on a display - Power supply by power adapter or four AA batteries - Single use microcuvettes (test consumable) - Labeling: - Operating Manual - Package Insert - Quick reference Guide - Labels The microcuvette serves both as a pipette and as a measuring cuvette. No dilution or other preparation of the blood sample is required before filling of the microcuvette. A whole blood sample of approximately 10 µL is drawn into the cavity in the microcuvette by capillary action. The measurement takes place in the analyzer, which measures the absorbance of whole blood at an Hb/ HbO2 isosbestic point. The measurement is performed directly on the whole blood through measurement of the transmitted and scattered light and using an algorithm for translation into the hemoglobin concentration of the sample. The HemoCue® Hb 301 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood.

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 HemoCue® Hb 801 System is intended for the quantitative determination of hemoglobin in capillary or venous whole blood (K2EDTA and Li-Heparin) in point-of-care settings. The HemoCue® Hb 801 System is intended to be used to determine the hemoglobin concentration for adults, adolescents, children, and infants above 1 month old. The HemoCue® Hb 801 System is for professional in vitro diagnostic use only.

The HemoCue® Hb 801 System provides a direct reading of the hemoglobin concentration in a sample using specially designed, single use microcuvette and an analyzer. The system can be used by non-laboratory personnel. The HemoCue® Hb 801 System consists of the following parts: - An analyzer supporting the following features: . - O Photometric determination of hemoglobin - Presentation of results on a display O - O Wired and wireless communication (USB and Bluetooth) - Power supply by power adapter, chargeable or non- chargeable batteries ● - Single use microcuvettes (test consumable) - Labeling: ● - O Operating Manual - o Package Insert - Quick reference Guide o - o Labels The microcuvette serves both as a pipette and as a measuring cuvette. No dilution or other preparation of the blood sample is required before filling of the microcuvette. A whole blood sample of approximately 10 uL is drawn into the cavity in the microcuvette by capillary action. The measurement takes place in the analyzer, which measures the absorbance of whole blood at an Hb/ HbO2 isosbestic point. The measurement is performed directly on the whole blood through measurement of the transmitted and scattered light and using an algorithm for translation into the hemoglobin concentration of the sample. The HemoCue® Hb 801 System is traceable to the hemiglobincyanide (HiCN) method, the international reference method according to ICSH for the determination of the hemoglobin concentration in blood.

The hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K2-EDTA, sodium citrate, lithium heparin, or sodium heparin). The testing system is designed for point-of-care settings, hospitals, and medical lab facilities. Estimation of hematocrit, as a function, is only for normal hemoglobin values, 12.0 to 180 g/dL) and in patients ≥ 6 months old. The hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS system in measuring the human hemoglobin concentration. The hemochroma PLUS Microcuvettes are only used with hemochroma PLUS Analyzer. The hemochroma PLUS System is for in vitro diagnostic only. The hemochroma PLUS Analyzer calculates the test result automatically and displays hemoglobin concentration in terms of g/dL.

The hemochroma PLUS Analyzer is a battery powered, hand-held device to measure the concentration of total hemoglobin in blood in 3 seconds with 15uL of whole blood. Whole blood may be collected by fingerstick (capillary) or venipuncture and analyzed without preprocessing. The hemochroma PLUS Analyzer uses hemochroma PLUS Microcuvettes with dual ports where the user applies samples either through capillary action or direct volume pipetting. The hemochroma PLUS Analyzer determines hemoglobin concentration in whole blood samples using a dual wavelength photo-absorption method and measures the degree of light absorption with a spectrophotometer. The optical distance between the hemochroma PLUS 3 Microcuvette walls is fixed and permits photometric determination of hemoglobin in undiluted blood samples. The computed end result is displayed on the LCD display and can be printed on an external printer (optional). The hemochroma PLUS System consists of a hemochroma PLUS Analyzer, single-use hemochroma PLUS Microcuvettes, hemochroma PLUS ID Chip, optical System Check Microcuvette and hemochroma PLUS Controls.

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 hemochroma PLUS System is for the quantitative determination of hemoglobin concentration in non-anticoagulated capillary (finger-stick) whole blood or venous whole blood (K.2-EDTA, sodium citrate, lithium heparin, or sodium heparin) of adults. The testing system is designed for point-of-care use in primary care settings, hospitals, and medical lab facilities. Estimation of hematocrit, as a function, is only for normal hemoglobin values from 12.0 to 18.0 g/ dL (120 to 180 g/L). The hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS system in measuring the human hemoglobin concentration. The hemochroma PLUS Microcuvettes are only used with hemochroma PLUS Analyzer. This device has not been evaluated for pediatric samples. The device has been evaluated for individuals ranging in age from 18 to 96 years old. The hemochroma PLUS System is for in vitro diagnostic only.

The hemochroma PLUS Analyzer is a battery powered, hand-held device to measure the concentration of total hemoglobin in blood in 3 seconds with 15ul of whole blood. Whole blood may be collected by fingerstick (capillary) or venipuncture and analyzed without pre-processing. The hemochroma PLUS Analyzer uses hemochroma PLUS Microcuvettes with dual ports where the user applies samples either through capillary action or direct volume pipetting. The hemochroma PLUS Analyzer determines hemoglobin concentration in whole blood samples using a dual wavelength photo-absorption method and measures the degree of light absorption with a spectrophotometer. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and permits photometric determination of hemoglobin in undiluted blood samples. The computed end result is displayed on a LCD display and can be printed on an external printer (optional). The hemochroma PLUS System consists of a hemochroma PLUS Analyzer, single-use hemochroma PLUS Microcuvettes, hemochroma PLUS ID Chip, optical System Check Microcuvette and hemochroma PLUS Controls. 1. hemochroma PLUS Microcuvette The hemochroma PLUS Microcuvettes are specially designed for use with the hemochroma PLUS Analyzer. The microcuvettes function as measuring devices specifically holding 15 uL of blood and are inserted into the hemochroma PLUS Analyzer by placing it into the cuvette holder. The optical distance between the hemochroma PLUS Microcuvette walls is fixed and by measuring the degree of light absorption permits photometric determination of the hemoglobin in undiluted blood samples. 2. hemochroma PLUS ID Chip The hemochroma PLUS ID chip contains encoded memory with the calibration data/information. With the ID chip inserted in the designated port, the hemochroma PLUS Analyzer reads and utilizes the calibration data regarding the lot under consideration and applies appropriate correction to the conversion formula while computing the test result. 3. hemochroma PLUS Optical System Check Microcuvette hemochroma PLUS Optical System Check Microcuvette is designed for use with the hemochroma PLUS Analyzer only. The Optical System Check Microcuvette is a special glass filter used to measure the degree of light absorption with the spectrophotometric method. If the result is between 11.7-12.3 g/dL, the optic system is working properly according to specification. 4. hemochroma PLUS Controls The hemochroma PLUS Controls: Level 1 (Low), Level 2 (Middle), and Level 3 (High), are external quality controls designed for use with hemochroma PLUS Analyzer only.

The Mission® Plus Hemoglobin (Hb) Testing System is for the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA ( K2, K3, Na2) or sodium heparin. The testing system is designed for point-of-care use in primary care settings. Estimation of hematocrit is only for hemoglobin values from 12.3 to 17.5 g/dL (123 to 175 g/L). The Mission® Plus Hemoglobin (Hb) Control Solution is intended to validate hemoglobin testing using the Mission® Plus Hemoglobin (Hb) Testing System. The Mission® Plus Hemoglobin (Hb) Testing System is for professional in vitro diagnostic use only.

The Mission® Plus Hemoglobin Testing System consists of The Mission® Hemoglobin (Hb) Testing Meter, Test cartridge, Control Solutions, and Optical Verifier. The Test cartridges are used with the Meter for monitoring Hemoglobin (Hb) and estimate the Hematocrit (Hct) within normal range of hemoglobin in capillary or venous whole blood. Red blood cells in the specimen are lysed to release Hb, which is converted into MHb. The shade of the color produced depends on the concentration of Hb. The Mission® plus Hemoglobin Testing System is a small, portable, battery-powered meter to measure total hemoglobin in combination of disposable test cartridge and requires no sample preparation or reagents. The portable meter analyzes the intensity and color of light reflected from the reagent area of a Test cartridge and provides results in less than 15 seconds. The test only requires a single drop of whole blood. The meter can store up to 1,000 results data and the data can be transferred to a computer for further analysis using the USB port. The meter can be powered by 4 AAA (1.5V) batteries or an optional AC adapter. The Mission® Plus Hemoglobin (Hb) Testing System contains an optical verifier which works with the Meter to ensure the optical detection is working properly. The Mission® Plus Hemoglobin (Hb) Control Solution is provided with 3 levels (0, 1, 2, ) of control solutions with known concentration of hemoglobin. It is used to confirm that the test meter and Test cartridges are working together properly. The product is a liquid, stable control prepared from bovine hemoglobin with added chemicals, preservatives (0.06%) and stabilizers (14.5% of sorbitol and sugar). The control does not contain products of human origins.

The Avie™ Total Hb Test System is for the quantitative measurement of total hemoglobin in whole blood (capillary or venous EDTA,K2). The test system is designed for point-of-care use in primary care settings. The test system is for professional in vitro diagnostic use only.

The Avie™ Total Hb Test System is a point of care (POC) IVD system that utilizes general chemistry reactions to quantify total hemoglobin in fresh capillary blood and venous blood. The test system includes a small instrument (Reader) and disposable reagent strips- the strips are packaged in a reusable canister with desiccant, similar to the packaging of routine urine test strips. The concentration of total hemoglobin is calculated photometrically and is based on the optical intensity of the reaction within the quantitative area of the test strip. The calibration of the Avie™ Total Hb Test is traceable to the same high-order reference method as the HemoCue (hemiglobincyanide [HiCN].

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).

The HemoPoint® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The HemoPoint H2 Microcuvettes are indicated for use in the HemoPoint® H2 DM Hemoglobin Measurement System. 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. The DM (Data Management) system allows enhanced data management features. For In Vitro Diagnostic Use Only

The HemoPoint® H2 Hemoglobin Measurement System is comprised of a HemoPoint® H2 Hemoglobin Photometer and HemoPoint® H2 Cuvettes. A modified azide methemoglobin method is used in the HemoPoint® H2 system. In the HemoPoint® H2, however, the use of microcuvettes with short light pathways makes it possible to analyze undiluted blood. The filled cuvette is inserted into the HemoPoint® H2 photometer, the color produced by the chemical reaction in the cuvette is measured, and the Hb level is calculated and displayed. In the HemoPoint® H2 photometer the light transmitted through the cuvette sample is measured. For this purpose, light is directed through the blood sample and the transmission T is measured. From the amount of light absorbed by the sample, the concentration of the hemoglobin in the cuvette can be calculated using Lambert-Beers Law. Light emitting diodes (LED's) are used as light sources and a photodiode to detect the light. The light emitting diodes utilize the central wavelengths 570 nm (for measurement) and 880 nm (for turbidity compensation). The DM (Data Management) software modification allows the storage and retrieval of data results along with patient information.