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The XR-Series module (XR-10) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XR-Series module classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, IPF#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2EDTA or K3EDTA anticoagulant, and serous and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

The Sysmex XR-Series module (XR-10) is a quantitative multi-parameter hematology analyzer intended to perform tests on whole blood samples collected in K2 or K3EDTA and body fluids (pleural, peritoneal and synovial) collected in K2EDTA anticoagulant. The analyzers can also perform tests on CSF, which should not be collected in any anticoagulant. The XR-Series analyzer consist of four principal units: (1) One Main Units (XR-10) which aspirates, dilutes, mixes, and analyzes blood and body fluid samples; (2) Two Auto Sampler Units (SA-10, SA-01) which supply samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit.

The XR-Series module (XR-20) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XR-Series module classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, IPF#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%/#, PMN%/#, and TC-BF# parameters in cerebrospinal fluid (CSF), serous fluids (peritoneal, pleural) and synovial fluids. Whole blood should be collected in K2EDTA or K3EDTA anticoagulant, and serous and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

The Sysmex XR-Series module (XR-20) is a quantitative multi-parameter hematology analyzer intended to perform tests on whole blood samples collected in K2 or K3EDTA and body fluids (pleural, peritoneal and synovial) collected in K2EDTA anticoagulant. The analyzers can also perform tests on CSF, which should not be collected in any anticoagulant. The XR-Series analyzer consist of four principal units: (1) One Main Unit (XR-20) which aspirates, dilutes, mixes, and analyzes blood and body fluid samples; (2) One Auto Sampler Unit which supply samples to the Main Unit automatically; (3) IPU (Information Processing Unit) which processes data from the Main Unit and provides the operator interface with the system; (4) Pneumatic Unit which supplies pressure and vacuum from the Main Unit. The XR-20 analyzer has an additional white progenitor cell (WPC) measuring channel and associated WPC reagents. The new WPC channel provides two separate flags for blasts and abnormal lymphocytes.

The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods. The performance of this device has not been established in neonate and pediatric patient populations.

The CN-Series (CN-6000) coagulation analyzer is an automated blood coagulation instrument which can analyze samples using clotting, chromogenic and immunoassay methods. Analysis results are displayed on the IPU (Information Processing Unit) screen. They can be printed on external printers or transmitted to a host computer. Sold separately from the instrument are the associated reagents, controls, calibrators, and consumable materials. The subject of this 510(k) notification is the analyzer together with the reagent applications which perform the coagulation tests: - Prothrombin Time (PT) seconds and PT INR with Dade® Innovin® - Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL - Fibrinogen (Fbg) with Dade® Thrombin Reagent - Antithrombin (AT) with INNOVANCE® Antithrombin - D-dimer with INNOVANCE® D-Dimer. The analysis principles used on the instrument are reflected by the reagent application testing provided in this submission and are described in the table below. These reagents were selected to show the analytical technology of the instrument while also selecting commonly used applications in coagulation laboratories in the United States.

The XQ-Series analyzer (XQ-320) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates the following parameters in venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, RDW-SD, RDW-CV, MPV, NEUT%/#, LYMPH%/#, and MXD%/#.

The Sysmex XQ-Series (XQ-320) automated hematology analyzer is a multi-parameter hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XQ-320 analyzer classifies and enumerates whole blood parameters by DC (Direct Current) detection method and non-cyanide HGB analysis method (Colorimetric method) on whole blood samples collected in K2 or K3EDTA anticoagulant. The XQ-320 analyzer consists of one unit which aspirates and dispenses diluent to prepare blood dilutions and analyzes whole blood samples. The operator must mix the sample manually then introduce the sample tube to the aspiration pipette with the cap off, and presses the start switch to execute aspiration and analysis. The XQ-320 analyzer uses a built-in monitor to operate the analyzer and process data.

The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#. It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/ disorders, oncology patients, critically ill patients, or children under the age of 2.

The XW-100 Automated Hematology Analyzer for CLIA Waived Use is an electrical resistance type blood cell counter. This technology may be variously referred to as direct current (DC) or impedance. The analyzer uses a human whole blood specimen and produces results for 12 hematology parameters, including the basic complete blood count (CBC), 3 part white blood cell (WBC) differential, and MCV.

The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in venous and capillary whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%/#, LYMPH%#, MON0%#, EO%#, IG%#, RDW-CV, RDW-SD, MPV, RET%#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%#, PMN%#, and TC-BF# parameters in cerebrospinal, peritoneal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDTA anticoagulant and peritoneal, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended.

The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates whole blood and body fluid parameters by means of electrical impedance, laser light scattering, and fluorescent labeling. Tests are performed on venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant and body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and cerebrospinal fluid that is not collected in anticoagulant. The instrument consists of two principal units: (1) Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer performs analysis using the following methods: DC Sheath Flow Detection Method, Flow Cytometry Methods using a Semiconductor Laser, and SLS-hemoglobin Method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results. The XN-L has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows operator interfacing with the instrument by use of a panel keyboard.

The Sysmex® UD-10 Fully Automated Urine Particle Digital Imaging Device for locating, digitally storing and displaying microscopic images captured from urine specimens. The Sysmex® UD-10 locates and presents particles and cellular elements based on size ranges. The images are displayed for review and classification by a qualified clinical laboratory technologist on the Urinalysis Data Manager (UDM). This device is intended for in vitro diagnostic use in conjunction with a urine particle counter for screening patient populations found in clinical laboratories.

The Sysmex® UD-10 is a medical device that captures images of cells and particles found in urine with a camera and displays the images on a display screen. The displayed data consists of images of individual particles that are extracted from the original captured whole field images. The device sorts urine particle images based on their size into eight groups (Class 1-8). These images are transferred to the UDM (Urinalysis Data Manager), where the operator enters the classification of the particle images based on their visual examination. The classification of the particles by the operator is a designation of what type of particles are observed (e.g., WBCs, RBCs, casts, bacteria).

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer analyzes the following parameters in urine samples: RBC, WBC, Epithelial cells, Cast, Bacteria and flags the presence of the following: Pathologic Cast, Crystals, Sperm, Yeast like cell and Mucus.

The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is an automated urine particle analyzer that is used in the clinical laboratory to analyze formed elements in urine samples quantitatively and flag for the presence of particles/cells in the sample. It provides screening of abnormal samples, as well as automation and better efficiency in the laboratory. The analyzer reports analysis results on five enumerated parameters in urine: RBC (Red Blood Cells), WBC (White Blood Cells), EC (Epithelial Cells), CAST and BACT (Bacteria). It also reports flagging information on the following parameters in urine: Pathologic Cast; Crystal; Sperm; Yeast like cell; and Mucus. This flagging information alerts the operator for the need of further testing and/or review. The Sysmex® UF-5000 Fully Automated Urine Particle Analyzer is a dedicated system for the analysis of microscopic formed elements in urine and uses a Microsoft® Windows Operating System. The analyzer consists of the following units: (1) Main Unit which aspirates, dilutes, mixes and analyzes urine samples and processes data from the main unit and provides the operator interface with the system; (2) Sampler Unit which supplies samples to the main unit automatically; and (3) Pneumatic Unit which supplies pressure and vacuum to the main unit. The analyzer uses five reagents-UF-CELLSHEATH (sheath reagent), UF-CELLPACK CR and UF-CELLPACK SF (diluents) and UF-Fluorocell CR and UF-Fluorocell SF (both stains). The quality control material is UF-CONTROL.

The XW-100 Automated Hematology Analyzer (XW-100) is a quantitative automated hematology analyzer intended for in vitro diagnostic use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, and NEUT#. It is not for use in diagnosing or monitoring patients with primary or secondary chronic hematologic diseases/ disorders, oncology patients, critically ill patients, or children under the age of 2.

The XW-100 Automated Hematology Analyzer is an electrical resistance type blood cell counter. This technology may be variously referred to as direct current (DC) or impedance. The analyzer uses a human whole blood specimen and produces results for 12 hematology parameters, including the basic complete blood count (CBC), 3 part white blood cell (WBC) differential, and MCV. The analyzer uses DC with hydrodynamic focusing for all parameters except hemoglobin, which is measured photometrically. The patient sample is aspirated, measured, diluted with diluent (and Lyse for WBC measurement), then fed into a transducer chamber by means of a hydrodynamic focusing nozzle. The transducer chamber has a minute hole, or aperture. Electrodes are mounted on both sides of the aperture chamber, through which flows the DC. Blood cells suspended in the diluted sample are injected through the aperture by the hydrodynamic focusing nozzle. The hydrodynamic focusing nozzle is positioned in front of the aperture and in line with the aperture's center. This method improves cell counting accuracy because all blood cells are separated from each other and can only pass through the aperture in 1 direction, 1 at a time. When a cell passes through the aperture, it causes a change in the DC resistance that is directly proportional to its size. These resistance changes are captured as electric pulses. The various blood cell counts are calculated by counting the pulses that occur in each cell size category. The analyzer then determines blood cell volume and identifies rare and pathological cells by creating and analyzing histograms of the various cell populations using their respective pulse heights. Hemoglobin is measured photometrically using a noncyanide methodology, which reduces the presence of hazardous materials in the analyzer waste stream. The quality controls that are used with the XW-100 CLIA Waived Automated Hematology Analyzer comprise XW QC CHECK, which contains stabilized red blood cell component(s), stabilized WBC component(s), and stabilized platelet component(s) in a preserving medium. XW QC CHECK components are packaged in glass vials with screw caps containing 2 mL. The vials are packaged in a welled vacuum- formed clamshell container. XW QC CHECK is stored at room temperature (15°C-25°C).

The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates the following parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, NEUT%H, LYMPH%4, MONO%#, EO%#, BASO%#, IG%#, RDW-CV, RDW-SD, MPV, RET%#, IRF, RET-He and has a Body Fluid mode for body fluids. The Body Fluid mode enumerates the WBC-BF, RBC-BF, MN%#, PMN%#, and TC-BF# parameters in cerebrospinal, pleural, and synovial fluids. Whole blood should be collected in K2 or K3EDT A anticoagulant and peritoneal, pleural, and synovial fluids in K2EDTA anticoagulant to prevent clotting of fluid. The use of anticoagulants with CSF specimens is neither required nor recommended. The performance of this device has not been established in pediatric patients under the age of 2 years.

The Sysmex XN-L analyzer is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XN-L analyzer classifies and enumerates whole blood and bodyfluid parameters by means of electrical impedance, laser light scattering, and fluorescentlabeling. Tests are performed on venous and capillary whole blood samples collected in K2 or K3 EDTA anticoagulant and body fluids (peritoneal, pleural and synovial) collected in K2EDTA anticoagulant and cerebrospinal fluid that is not collected in anticoagulant. The instrument consists of two principal units: (1) Main Unit which will aspirate, dilute, mix, and analyze whole blood and body fluid samples and (2) Pneumatic Unit which supplies pressure and vacuum to the analyzer. The XN-L analyzer performs analysis using the following methods: DC Sheath Flow Detection Method, Flow Cytometry Methods using a Semiconductor Laser, and SLS- hemoglobin Method. Particle characterization and identification is based on detection of forward scatter, fluorescence, and adaptive cluster analysis. The XN-L analyzer automatically classifies cells from whole blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results. The XN-L has an external monitor with touch screen capability that is used to operate the instrument and process data from the Main Unit. The monitor also allows operator interfacing with the instrument by use of a panel keyboard.