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The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. The ClearLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios, Navios EX and DxFLEX flow cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. These reagents provide multiparameter, qualitative results for the surface antigens listed below: - ClearLLab 10C B Cell Tube: Kappa, Lambda, CD10, CD5, CD200, CD34, CD38, CD20, CD19, CD45 - ClearLLab 10C T Cell Tube: TCRy6, CD4, CD2, CD56, CD5, CD34, CD3, CD8, CD7, CD45 - ClearLLab 10C M1 Cell Tube: CD16, CD7, CD10, CD13, CD64, CD34, CD14, HLA-DR, CD11b, CD45 - ClearLLab 10C M2 Cell Tube: CD15, CD123, CD117, CD13, CD33, CD34, CD38, HLA-DR, CD19, CD45

The ClearLLab 10C Reagent System is currently cleared on the Navios EX Flow cytometer under K183592. Beckman Coulter has developed the DxFLEX Flow Cytometer, a next generation flow cytometer that offers enhanced performance in terms of optics and electronics, as well as more convenient installation and operation. The indications for use of the ClearLLab 10C Reagent System will be expanded to include its use on the DxFLEX Flow Cytometer. Furthermore, the indications for use will be clearly stated on labeling. The intended use of the ClearLLab 10C Reagent System will not be modified. ClearLLab 10C Reagent System components that are included with use on the DxFLEX Flow Cytometer: - DxFLEX Flow Cytometer [3 laser/10 color configuration] [New] - DxFLEX Daily OC Fluorospheres [New] - ClearLLab 10C Panels [B, T, M1 and M2] [Modification to Existing] - ClearLLab Compensation Kit [Modification to Existing] - ClearLLab Compensation Beads [Modification to Existing] - ClearLLab Control Cells, normal and abnormal [Modification to Existing] - Kaluza C data analysis software [Existing] - IOTest 3 Fixative Solution [Existing] - IOTest 3 Lysing Solution [Existing] The ClearLLab 10C Reagent System is run on Beckman Coulter's DxFLEX Flow Cytometer (3 Laser/10 Color configuration]. The DxFLEX Flow Cytometer includes the hardware and CytExpert for DxFLEX software. It requires off-line manual sample processing and use of the accompanying lysing reagent. As part of the ClearLLab 10C Reagent System, to allow proper utilization of this applications for the DxFLEX flow cytometers include ten fluorescent detection channels (FL1-FL10) and three laser configurations (blue, red and violet). As with the workflow on the predicate system, LMD data analysis is performed manually using the Kaluza C Analysis Software. This Analysis Software package is supplied separately from the DxFLEX and must be installed on an independent computer workstation for off-line analysis of listmode files generated on the flow cytometer with the associated reagents and cytometer system software package, including Control Cell QC data and sample data analysis. The CvtExpert for DxFLEX software is NOT be recommended for analysis use with this application (Note that OC data DxFLEX Daily OC Fluorospheres and Compensation products will continue to be analyzed using the on-board instrument software). Kaluza C Software is a software tool designed to work with *.fcs and *.lmd files generated from flow cytometers. The advantages of using the Kaluza C over the CytExpert for DxFLEX software are listed below: - Powerful processing speed allows fast analysis of listmode data, including real-time updating of gating and compensation - Plot displays are more versatile allowing linear, logarithmic and 'Logicle' (linear/log hybrid) axes as well as configurable scaling and zooming options - Range of compensation options - QC reporting includes Levey-Jennings plots and highlighted pass/fail criteria on results displays Preset Kaluza C analysis templates for the ClearLLab 10C reagent system will be provided. The total WBC gate is defined in the histogram of SS vs. CD45-KO525-A by the inclusion of all CD45+ events with low, medium and high Side Scatter after the exclusion of the cells that were compromised and/or aggregated. A subsequent histogram defines specific leukocyte subset such as lymphocytes, monocytes, granulocytes. The low SS/bright CD45+ population identifies lymphocytes. Applicable markers are then displayed in subsequent histograms gated on lymphocytes. This process is repeated for mid SS/medium CD45+ populations to identify monocytes and for high SS/medium CD45+ to identify granulocytes.

The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. The BD FACSLyric™ flow cytometer with the integrated BD FACSDuet™ System is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) aser. It includes an automated sample preparation system used to prepare human peripheral whole blood samples for acquisition and analysis and is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

The BD FACSLyric™ Flow Cytometer is a flow cytometer system. The BD FACSLyric™ Flow Cytometer with the integrated BD FACSDuet™ Sample Preparation System includes the flow cytometer and an automated sample preparation system. The system includes the BD FACSLyric™ Flow Cytometer, BD FACSTM Universal Loader, BD FACSuite™ Clinical software, BD FACSDuet™ Sample Preparation System, BD Multitest™ 6- Color and 4-Color Assay Modules, BD® FACSFlow™ Sheath Fluid, BD® CS&T Beads, and BD® FC Beads 7-Color Kit. It uses flow cytometry and immunofluorescence assay methodology.

The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4, and BD Multitest™ CD3/CD16+CD56/CD45/CD19, all with optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets: BD Multitest 6-color TBNK with optional BD Trucount tubes - · T lymphocytes (CD3+) - · B lymphocytes (CD19+) - · Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+) - · Helper/inducer T lymphocytes (CD3+CD4+) - · Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest IMK kit with optional BD Trucount tubes - · T lymphocytes (CD3+) - · B lymphocytes (CD19+) - · Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+) - · Helper/inducer T lymphocytes (CD3+CD4+) - · Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes - · T lymphocytes (CD3+) - · Suppressor/cytotoxic T lymphocytes (CD3+CD8+) - · Helper/inducer T lymphocytes (CD3+CD4+) BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes - · T lymphocytes (CD3+) - · Natural killer (NK) lymphocytes (CD3-CD16+ and/or CD56+) - · B lymphocytes (CD3-CD19+)

The BD FACSLyric Flow Cytometer consists of the following components. - FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations) - FACSuite Clinical Software - Multitest 6-Color Assay Modules - Multitest 4-Color Assay Modules - FC Beads 7-Color Kit - CS&T Beads - Multitest 6-Color TBNK - Multitest IMK Kit - . Multitest CD3/CD8/CD45/CD4 - Multitest CD3/CD16+CD56/CD45/CD19 - . Multi-Check Control - . Multi-Check CD4 Low Control - . Trucount Tubes - Optional FACS Universal Loader The system is an immunofluorescence assay system for identification and enumeration of lymphocyte subsets in peripheral whole blood. When blood is added to the monoclonal antibody reagent, the fluorochrome-labeled antibodies in the reagent bind specifically to lymphocvte surface antigens. During acquisition, the cells travel past one or more laser beams in a single file and scatter the laser light. The stained cells fluoresce. The scatter and fluorescence light is detected by the flow cytometer, separated by dichroic mirrors and optical filters, and then quantified with photomultiplier tubes (PMTs) to determine the percent lymphocyte of particular cell populations. Multiple monoclonal antibodies each labeled with a different fluorochrome are contained within one reagent tube to simultaneously identify multiple lymphocyte subset populations. The use of Trucount tubes provides the absolute number of the fluorochrome-labeled antibody bound cells.

The Navios EX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to four fluorescent detection channels using a blue (488 nm) laser and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. The Navios EX tetra Software is intended for use as an in vitro diagnostic device for immunophenotyping with CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/ CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 monoclonal antibody reagents on the Navios EX Flow Cytometer. It provides automated analysis and results for the identification and enumeration of CD3+CD4+, CD3+CD8+, CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in peripheral whole blood. Absolute counts may be determined by the Navios EX Flow Cytometers using Flow-Count Fluorospheres (Single Platform Technology (SPT) Method) or separate hematology results (Dual Platform Method). It is indicated for use in the immunologic assessment of patients having or suspected of having immune deficiency.

The Navios EX Flow Cytometry System consists of: - Navios EX Flow Cytometer - Navios EX tetra Software - Navios EX Software off-line analysis tool - CYTO-STAT tetraCHROME reagents - Flow-Set Pro Fluorospheres - Flow-Check Pro Fluorospheres - Flow-Count Fluorospheres - Immuno-Trol Cells - Immuno-Trol Low Cells - COULTER IMMUNOPREP Reagent System - QuickCOMP 2 and QuickCOMP 4 Kits - CYTO-COMP Cell Kit - ISOFLOW Sheath Fluid - FlowClean Cleaning Reagent - TQ-Prep Workstation (accessory for sample preparation) - PrepPlus 2 Workstation (accessory for sample preparation) The Navios EX Flow Cytometry System is the next generation product in the Navios Flow Cytometry family. With the Navios EX flow cytometer and associated software, the following modifications have been introduced: - Replacement of optical assemblies and flow cell - Replacement of the existing 488nm laser with a comparable 488nm laser - Replacement of the band-pass filter (FL3) used for ECD dye - Replacement of the Forward Scatter mask with a new mask configuration - Replacement of the existing fixed aspiration probe with an adjustable one. This probe is adjusted by the service engineer only to account for the sample tube employed at the customer's laboratory. - Change to the optics module temperature management hardware - Minor change to the sheath pressure - Minor changes to the Navios EX tetra algorithm

The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 mm) laser, two light scatter detection volume (EV). It is used in conjunction with the following reagents and software package. AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of; - AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent · Total CD3+, CD3+CD4+,CD3+CD3+, CD3+CD4+/CD3+CD8+ (ratio only) lymphocyte percentages and absolute counts. • CD45+ absolute count - · CD45+ Low SS (lymphocytes) percentage and absolute count AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent - · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts. - CD45+ absolute count - · CD45+ Low SS (lymphocytes) percentage and absolute count AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with the monoclonal antibody reagents listed above. The off-line analysis must be performed in accordance with the product labeling. AQUIOS Tetra-1 Panel and AQUIOS Tetra-2+ Panel monoclonal antibody reagents are for use on the AQUIOS CL Flow Cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunologic assessment of patients having, or suspected of having, immune deficiency. These reagents provide identification and enumeration of; - AQUIOS Tetra-1 Panel Monoclonal Antibody Reagent · Total CD3+, CD3+CD4+,CD3+CD8+, CD3+CD4+/CD3+CD8+(ratio only) lymphocyte percentages and absolute counts. - CD45+ absolute count - · CD45+ Low SS (lymphocytes) percentage and absolute count - AQUIOS Tetra-2+ Panel Monoclonal Antibody Reagent - · Total CD3+, CD3-CD19+, CD3-CD56+ and/or CD16+ lymphocyte percentages and absolute counts. - CD45+ absolute count - · CD45+ Low SS (lymphocytes) percentage and absolute count AQUIOS IMMUNO-TROL Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer. AQUIOS IMMUNO-TROL Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer. AQUIOS Lysing Reagent Kit is used as part of the AQUIOS flow cytometer system. The kit consists used by AQUIOS flow cytometers to prepare whole blood samples for analysis of white blood cells.

The AQUIOS CL Flow Cytometry System is composed of the following components: - . AQUIOS CL Flow Cytometer - AQUIOS System Software ● - AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 ● - AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 ● - AQUIOS Immuno-Trol Cells ● - AQUIOS Immuno-Trol Low Cells ● - . AQUIOS Lysing Reagent Kit The AQUIOS CL Flow Cytometer uses flow cytometric principles to determine qualitative and quantitative measurements of biological and physical properties of cells and other particles. These properties are measured when the cells pass through the laser beam(s) in single file. The AQUIOS System Software is designed for the AQUIOS CL flow cytometer. It includes the algorithms and test definitions that provide automated analysis and results for AQUIOS Tetra-1 and 2+ reagents; this application cannot be modified by the user. The AQUIOS Flow Cytometry System also offers an optional standalone offline workstation. This workstation is identical to the workstation that is physically connected to the instrument and can be used for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with AQUIOS Tetra-1 and Tetra-2+ reagents and AQUIOS System software according to the product labeling. AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 reagent provides identification and enumeration of CD45+, CD45+ Low SS, and CD3+/CD4+, CD3+/CD8+, and CD3+ lymphocyte percentages and absolute counts in peripheral whole blood. AQUIOS Tetra-2+ Panel CD45-FITC/(CD56+CD16)-RD1/CD19-ECD/CD3-PC5 provides identification and enumeration of CD45+, CD45+ Low SS, and CD3+, CD3-/CD19+ and CD3-/CD56+CD16+ lymphocyte percentages and absolute counts in peripheral whole blood. Additionally, both panels provide for CD45+ absolute count and CD45+ Low SS absolute count and percentage. AQUIOS Immuno-Trol and Immuno-Trol Low Cells are assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytometry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of instrument and reagent performance. It also verifies the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by the AQUIOS CL Flow Cytometer. The AQUIOS CL Flow Cytometer uses on-board sample preparation as part of the overall system workflow. The AQUIOS Lysing Reagent Kit is comprised of two readyto-use reagents: Reagent A lyses the red blood cells, Reagent B quenches the solution, slowing the lyse reaction down in preparation for analysis. This reagent system provides a rapid, no-wash, standardized, whole blood lysing solution for sample to sample, and laboratory to laboratory reproducibility.

The BD FACSCanto flow cytometer (4-3-3 configuration) functions as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (640 mm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III. For in vitro diagnostic use. The BD FACSCanto II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 mm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III. For in vitro diagnostic use.

The BD FACSCanto and FACSCanto II (BD FACSCanto II 4-2-2, BD FACSCanto II 5-3 and BD FACSCanto 4-3-3 configurations) are comprised of a flow cytometer, a fluidics cart, and a computer workstation. The flow cytometer acquires and analyzes the sample, the fluidics cart contains operational fluids, and the computer displays and prints the analysis. The flow cytometer utilizes three subsystems: fluidics, optics, and electronics. The computer workstation runs two software packages: BD FACSCanto clinical software for automatic immunophenotyping assays prepared using the lyse/wash or lyse/no-wash methods, and BD FACSDiva software for installation, service, and manual user-validated applications. The BD FACSCanto and FACSCanto II systems can optionally be used with the BD FACSLoader for automatic sample introduction, a standalone barcode reader for data input into BD FACSCanto clinical software and BD FACSDiva software, and/or the BD FACS Sample Prep Assistant III for automatic sample preparation of assays utilizing the lyse/no-wash method.

The Navios Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It can be used in conjunction with the following monoclonal antibody reagents and software package: • CYTO-STAT letraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT terrCHROME CD45-FITC/CD56-F • C Y (O-S FAT TetraCHKOME CD4-FFTCCO4+KD7/CDV-Fc2/CD3 P ovide identification and numeration of CD3+CD4+CD4+CD4+CD4+CD4+ KDI/CDI9-ECD/CD3+CS monocolal antibody reagains. There reges and absolute counts in peripleral whole blood. Absolute method) CD3+CD8+, CD3+, CD19+ and CD3-CD3+ Tymphoeyto percomes (single platform lections of the may be in closing acrescription of parient counts may be celermined by the Navio Cyclinece asng I to "Outlier" (o" on the in the immunologic assessment of patients having or suspected of having immune deficiency. • Navios tetra Software for automated and results with CYTO-STAT terraCHRONE CD45-FFTC/CD4-RD/VCD8-ECD/CD3-FCD/CD3-• Navios letta Soltware for adionated and results will of 10 0 010 11:40 pm PC5 and CYTO-STAT ietraCHROME CD45 FITC/CD56-RDI/CD19-ECD/CD3-PCS monoclonal antibody reagents. PC Navios Software may be installed on an independent computer workstarion for off issues of listed of line against must he Navios Soltware may be installed on the incependent compaise frectorial and software package listed above. The off-line analysis must be performed in accordance with the product labeling. The Navios tetra Software is intended for use as an in vitro diagnostic device for immunophenoyping with CYTC/CDS6 RD/A The Navios tera Software is mielided to use as an in Thir Glightshouse on minutes of the Subsition of the National Provincial Provinces of CD19-FITC/CD56-RDI/CD19-ECV/ CD3-PC5 monoclonal antibody reagents on the Navios Flow Cytometer. It provides automated analysis and results for the identification and enumeration of CD3+CD4+, CD19+, CD19+, and If provides and results for the nemation and while blood. Absolute counts may be determined by the except of the CD3+CD5+ iymphocyte percentages and alsolute counts in perfined in separate hematology results (dual Navios now cycomerer use in the immunologic assessment of patients having or suspected of having immune deficiency. platform method). It is indicated for use in the immunolog Flow-Set Pro Fluorospheres is a suspension of fluorescent microspheres used as an aid in standardizing forward scatter, side scatter, and fluorescence detectors (FL1-4) on the Cytomics FC 500 and Navios Flow Cytometers.

The Navios Flow Cytometer system is composed of the following components: - Navios Flow Cytometer . - Navios tetra Software . - Navios Software (off-line analysis tool) . - Flow-Set Pro Fluorospheres . - CYTO-STAT teiraCHROME reagents . - COULTER IMMUNOPREP Reagent System . - TQ-Prep Workstation (Accessory for Sample Preparation) . - PrepPlus™ 2 Workstation (Accessory for Sample Preparation) . The Navios Flow Cytometer uses flow cytometric principles to determine qualitative and quantitative measurements of biological and physical properties of cells and other particles. These properties are measured when the cells pass through the laser beam(s) in single file. The Navios tetra software is an optional locked algorithm application plug-in that is designed for the Navios flow cytometer. It provides automated analysis and results for tetraCHROME reagents; this application cannot be modified by the user. The Navios Flow Cytometry System also offers an optional standalone offline software package, Navios software, which may be installed on an independent computer workstation for off-line analysis of listmode files generated by the Navios Flow Cytometer with tetraCHROME reagents and Navios tetra software according to the product labeling. tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 CYTO-STAT reagent provides identification and enumeration of CD3+CD4+, CD3+CD8+, and CD3+ lymphocyte percentages and absolute counts in peripheral whole blood. CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 reagent provides identification and enumeration of CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in peripheral whole blood. Flow-Set Pro Fluorospheres is a suspension of fluorospheres with uniform and stable size and fluorescence intensity. The stability of these product parameters allows for the standardization of light scatter and fluorescence intensity instrument settings. The COULTER ImmunoPrep Reagent System is comprised of 3 ready-to-use reagents: Reagent A lyses the red blood cells, Reagent B buffers the solution and stops the lysing process, and Reagent C fixes the cells. This reagent system provides a rapid, no-wash, standardized, whole blood lysing solution for sample to sample, and laboratory to laboratory reproducibility. The Navios Flow Cytometer uses sample preparation devices as part of the overall workflow system. The COULTER TQ-Prep Workstation is used with the COULTER ImmunoPrep Reagent System to prepare leukocytes from whole blood for quantitative immunofluorescence measurements on flow cytometers. The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

tetraCHROME Reagents: CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents are for use on the COULTER EPICS XL/XL-MCL and Cytomics FC 500 Flow Cytometers. The reagents may also be used with the tetraONE SYSTEM for COULTER EPICS XL/XL-MCL Flow Cytometers or with tetraCXP SYSTEM for Cytomics FC 500 Flow Cytometers. Used alone or in combination with the automated systems, the reagents are intended "For In Vitro Diagnostic Use" and allow simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5. tetraCXP SYSTEM: The tetraCXP Software for Cytomics FC 500 flow cytometry systems, CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and CYTO-STAT tetraCHROME CD45-FITC/CD56-RDI/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents combine four-color fluorescent monoclonal antibody reagents, quality control reagents, an optional absolute count reagent, and software for automated analysis of lymphocyte populations in whole blood using Cytomics FC 500 flow cytometry systems with CXP Software. The system with CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ T lymphocyte population percentages and absolute counts. The system also provides the CD4/CD8 ratio. The system with CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of total CD3+ (T), CD19+(B), and CD3-/CD56+ (NK) lymphocyte population percentages and absolute counts. This reagent reflects the distribution of the three major subsets comprising the lymphocyte population upon which other lymphocyte enumeration studies are based.

CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent: This monoclonal antibody reagent identifies a lymphocyte gate based on CD45 bright positive staining (vs. side scatter) and allows simultaneous identification and enumeration of total CD3+, total CD4+ total CD8+, dual-positive CD3+/CD4+ and dual-positive CD3+/CD8+ lymphocytes in whole blood by flow cytometry. The reagent is comprised of four murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent is for use on the COULTER EPICS XL/XL-MCL and Cytomics FC 500 Flow Cytometers with a manual gating procedure provided in the reagent product labeling. The reagent may also be used with the automated algorithm gating provided by tetraONE SYSTEM for COULTER EPICS XL/XL-MCL Flow Cytometers or tetraCXP SYSTEM for Cytomics FC 500 Flow Cytometers. CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent: This monoclonal antibody reagent identifies a lymphocyte gate based on CD45 bright positive staining (vs. side scatter) and allows simultaneous identification and enumeration of total CD3+, CD19+ and CD3-/CD56+ lymphocytes in whole blood by flow cytometry. The reagent is comprised of four murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent is for use on the COULTER EPICS XL/XL-MCL and Cytomics FC 500 Flow Cytometers with a manual gating procedure provided in the reagent product labeling. The reagent may also be used with the automated algorithm gating provided by tetraONE SYSTEM for COULTER EPICS XL/XL-MCL Flow Cytometers or tetraCXP SYSTEM for Cytomics FC 500 Flow Cytometers. tetraCXP SYSTEM: tetraCXP SYSTEM for the Cytomics FC 500 with CXP Software consists of tetraCXP SYSTEM application software, tetraCHROME monoclonal antibody reagents, quality control reagents, an optional absolute count reagent, and automated software on the Cytomics FC 500 Flow Cytometer. The system with CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 allows for simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+ and dual CD3+/CD8+ T lymphocyte population percentages and absolute counts. The system also provides the CD4/CD8 ratio. The system with CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of total CD3+ (T), CD19+ (B), and CD3-/CD56+ (NK) lymphocyte population percentages and absolute counts. The tetraCXP SYSTEM Software comprises two functions: an Auto-Set Panel and an Automated Analysis Algorithm. The Auto-Set Panel automatically standardizes the cytometer, adjusts compensation settings, passes cytometer settings to designated test protocols, and verifies cytometer setup and antibody performance. Compensation settings are determined using QuickCOMP 4 Cells. The Automated Analysis Algorithm works in conjunction with the tetraCHROME monoclonal antibodies to automatically identify and enumerate sample populations.