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The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitation of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes.

The GloCyte® Automated Cell Counter System is an automated cell counter that concentrates and enumerates total nucleated cells (TNCs) and red blood cells (RBCs) using fluorescent microscopy and digital image analysis principles. The test method uses one of two reagents to stain TNCs (propidium iodide with detergent) or RBCs (fluorochrome labeled anti- human RBC antibody in buffer with stabilizers), and a digital imaging system to count the cells. The image is captured by a digital CCD camera, and the fluorescent stained cells are counted via digital image processing. The GloCyte® Automated Cell Counter System includes the Instrument, Computer (hardware & software), Vacuum Station, Sample Preparation Tray, Barcode Reader, Pipettes (10 and 30 µL), Test Cartridge, TNC and RBC Reagents, Low and High Level Controls.

The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by an appropriately trained laboratory user to examine and count red blood cells and nucleated cells in cerebrospinal fluid, serous fluids and synovial fluid. This module is a capability added to the iQ®200 Urine Analyzer.

The iQ®200 Urine Analyzer Body Fluids Module for use with synovial fluid is an additional use for the iQ®200 Urine Analyzer (K022774 – cleared October 21, 2002). It is used by a competent human observer to examine and count red blood cells and nucleated cells in synovial fluid and is an added body fluid to the previously cleared iQ®200 Urine Analyzer Body Fluids Module cerebrospinal and serous fluids (K050235 -Cleared March 23, 2005).

The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) count in capillary or venous whole blood. The HemoCue WBC system is for In Vitro Diagnostic use only. The HemoCue WBC Analyzer is only to be used with HemoCue WBC Microcuvettes. The HemoCue WBC system is indicated for use in clinical laboratories and for point-of-care settings.

The system consists of the HemoCue WBC Analyzer together with specially designed microcuvettes, the HemoCue WBC Microcuvettes. The microcuvette serves both as a sample container and a reaction chamber. A blood sample of approximately 10 uL is drawn into the cavity by capillary action. A hemolysing agent lyses the red cells in the microcuvette and a staining agent colors the white blood cells. An image is taken of the stained white blood cells and the number of cells is counted by image analysis. The result is presented within 3 minutes on the analyzer's display. The system reports results in the measuring range 0.3 - 30.0 x107/L. The system is factory calibrated and needs no further calibration. The HemoCue WBC Analyzer is a portable device. The main parts are the cuvette holder (in which the microcuvette is placed), the cuvette moving arm (brings the microcuvette into correct measuring position), a magnifying optic unit, a camera, image processing software, a display and a power adapter. The HemoCue WBC Microcuvette is made of polystyrene plastic and contains saponin that hemolyzes the red blood cells, methylene blue that stains the white blood cells and nonactive reagents. A blood sample of approximately 10 µL is drawn into the cavity by capillary action. The microcuvette serves as a sample container and a reaction chamber. No dilution of the sample is required.

The ADVIA® 2120 Nucleated Red Blood Cell (nRBC) method is intended to provide an in vitro diagnostic, quantitative determination of nucleated red blood cells in peripheral whole blood.

The technological and methodological principles of the ADVIA 2120 with Autoslide used for the quantitative measurement of blood cells in whole blood specimens will be used without change except for the addition of a new methodology to quantitate nucleated red blood cells and correct for white blood cells in peripheral whole blood. The ADVIA 2120 Nucleated Red Blood Cell (nRBC) method is described below: a) The ADVIA 2120 nRBC Analysis method uses histogram analysis routines to analyze the unstained region of the Peroxidase channel as well as an arithmetic algorithm that combines counts from the Peroxidase and Basophil/Lobularity channels to enumerate nRBCs. b) The analysis corrects the White Blood Cell Count for the presence of nRBCs, as well as the WBC Differential. It reports the corrected WBC count and the corrected differential. The new nRBC method will report the following Red Blood Cell Parameters- 1) % nucleated Red Blood Cells (% nRBC) 2) absolute nRBC (# of nRBC per microliter)

The iQ 200 Urine Analyzer Body Fluids Module is an in-vitro diagnostic device used by a competent human observer to examine and count red blood cells and nucleated cells in cerebrospinal fluid and serous fluids. Cerebrospinal fluid analysis is ordered by physicians to diagnose meningitis, intracranial hemorrhage, leukemias, malignancies and central nervous system disorders. Serous fluid analysis is ordered by physicians to diagnose infections, hemorrhages, malignancies and other disorders. Cell count determination is a part of these analyses. The information produced by the iQ 200 Urine Analyzer Body Fluids Module concerning the cell concentrations in CSF and serous body fluids is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Cell count findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

Two aliquots from each body fluid specimen sample are prepared. One aliquot is diluted in normal saline to provide a concentration in the linear range of the instrument. The second aliquot is treated with a lysing reagent to allow unambiguous identification of nucleated cells by eliminating RBC confusion. Particle images are captured and saved electronically as the sample flows past a microscope objective at a high speed, electronically concentrating particles. Particle images are then ordered by size into assigned categories on a video display. A competent human observer may change machine assignments, after which particle concentrations are recomputed and reported.

The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in a CLIA non-waived clinical laboratory (not for Point of Care Use in a CLIA waived laboratory). This instrument provides results for the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#, RDW-SD, RDW-CV, MPV.

The Sysmex pocH-100i is an automated hematology analyzer for use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory).

The ADVIA 120 cerebrospinal fluid (CSF) cell count is intended to provide an in vitro diagnostic, quantitative determination of blood cells in CSF specimens analyzed in the manual open tube mode. The ADVIA 120 provides leukocyte (WBC) and erythrocyte (RBC) counts along with both absolute and proportional counts for the WBC differential.

The revised ADVIA 120 CSF method consists of the following changes to the ADVIA 120 Hematology System. 1. A reformulated reagent that can be used to obtain CSF counts from a single optical channel of the ADVIA 120 system. 2. Revised software to calculate the cell counts. 3. A software key to selectively allow access to the CSF mode of the system software. 4. Control products to maintain quality control of the CSF method. The following parameters are reported with the ADVIA 120 CSF method: White Blood Cell Parameters WBC - white blood cell count Neut - neutrophil count (percentage and absolute counts) Lymph - lymphocyte count (percentage and absolute counts) Mono - monocyte count (percentage and absolute counts) Eos - eosinophil count (percentage and absolute counts) MN - mononuclear count (percentage and absolute counts) PMN -- polymorphonuclear count (percentage and absolute counts) Red Blood Cell Parameters RBC - red blood cell count * For Laboratory Use Only (not reportable)

The COULTER® Z2 instrument may be used for in vitro diagnostic use to determine the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt). In addition, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV).

The COULTER Z2 is a general purpose dual threshold particle counter and sizer designed to count and size particles, suspended in an aqueous electrolyte solution, within the range of 1 to 120 um equivalent spherical diameter. The instrument is designed for both biological and industrial use. As with the predicate devices, the COULTER Z2 utilizes the Coulter principle for the enumeration and sizing of blood cells. The same reagent system, composed of an isotonic diluent, lytic reagent to lyse red blood cells for WBC measurement and instrument cleaner, is used on COULTER STKS, Z1, and Z2 instruments. The COULTER STKS, Z1, and Z2 instruments are capable of determining the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt). In addition, like the COULTER STKS, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV). Both the COULTER Z1 and the Z2 instruments contain a hydraulic metering station built into the electronics main unit, measure a restricted range of particle sizes (within the range 1 to 120 µM) and utilize surface-mount technology. Operator-adjustable controls are accessible by means of a keyboard data terminal.

The intended use of the Sysmex R-3500 is as a fully automated reticulocyte analyzer for in vitro diagnostic use in clinical laboratories.

The Sysmex™ R-3500 is an automated reticulocyte analyzer intended for in vitro use in clinical laboratories. The R-3500 provides accurate and precise test results for 8 analysis parameters in whole blood. These include RET%, RET#, RBC, IRF, LFR, MFR, HFR, and PLT. The R-3500 processes approximately 120 samples per hour and displays and prints the data for Reticulocyte number, Reticulocyte percent, Red blood cell count, Immature reticulocyte fraction, fluorescent ratios, and platelets along with representative scattergrams. Sample abnormalities are indicated by abnormal marks, flags, and error messages which appear on the DMS display screen and on the printout. This is an indication that the sample is not within the acceptable range and requires further review and investigation. The R-3500 uses the principle of flow cytometry for reticulocyte analysis. In the instrument, a whole blood sample is automatically aspirated, diluted and stained with a fluorescent dye (Auromine-O). The sample is hydrodynamically focused into a narrow path and passed through a flow cell, where it is illuminated by an Argon laser beam. The cells present in the sample will fluoresce and scatter light to varying degrees. It is the analysis of the intensity of emitted fluorescent light and intensity of scattered light which allows the R-3500 analyzer to detect and enumerate reticulocytes.