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The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios EX 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, non-Hodgkin lymphoma, myeloma, myeloma, 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: TCRy8, 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, CD34, CD38, HLA-DR, CD19, CD45 The Navios 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, 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 Navios EX 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, and 405 mm) 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 new ClearLLab 10C reagent system is comprised of various components and is described below. Figures 2 and 3 illustrate the anticipated workflow from instrument setup through data analysis with a breakout of the standardization and Quality Control sequence for the new reagent system. As the figures show, the process is in-line with standard flow cytometry protocol. - Four ClearLLab 10C Panels [B, T, M1 and M2] - Navios and Navios EX flow cytometers [3 laser/10 color configurations] - ClearLLab Compensation Kit - ClearLLab Compensation Beads - ClearLLab Control Cells, normal and abnormal - Kaluza C data analysis software - Flow-Check Pro Fluorospheres - Flow-Set Pro Fluorospheres - IOTest 3 Fixative Solution - IOTest 3 Lysing Solution The ClearLLab 10C reagent system is run on Beckman Coulter's Navios or Navios EX flow cytometer (3 Laser/10 Color configurations). 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 application, the indications for the Navios and Navios EX flow cytometers include all ten fluorescent detection channels and three laser configurations (blue, red and violet). LMD data analysis is performed manually using the Kaluza C Analysis Software. This Analysis Software package is supplied separately from the Navios EX system softwares 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 OC data and sample data analysis. The Navios and Navios EX analysis software are NOT be recommended for use with this application (Note that QC data from Flow-Set Pro, Flow-Check Pro, 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 *.Imd files generated from flow cytometers. Preset Kaluza C analysis templates for the ClearLLab 10c reagent system are provided.

The ClearLLab reagents are intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on an FC 500 flow cytometer. 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, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood collected in EDTA (K2 and K3EDTA), Acid Citrate Dextrose 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 Cluster of Differentiation (CD) parameters listed below: - ClearLLab T1: CD2, CD56, CD7, CD5, CD7, CD5, CD45 - ClearLLab T2: CD8, CD4, CD3, CD45 - ClearLLab B1: Kappa, Lambda, CD19, CD5, CD45 - ClearLLab B2: CD20, CD10, CD10, CD19, CD38, CD45 - ClearLLab M: CD7, CD13, CD34, CD33, CD45

The Clear LLab Reagents panel is used with the following reagents with their respective indicated uses. A description of the reagents provided is described below in Table 1. | Item | Description | Use | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The T-Cell Lineage panels | Comprising T1 CD2-<br>FITC/CD56-PE/CD7-<br>ECD/CD5-PC5.5/CD45-PC7<br>and T2 CD8-FITC/CD4-<br>PE/CD3-PC5.5/CD45-PC7<br>Monoclonal Antibody Reagents. | For use to identify lymphocytes<br>that contain the specific cell<br>surface markers associated with<br>the T-cell lineage. | | The B-Cell Lineage panels | Comprising B1 Kappa- | For use to identify lymphocytes | | | FITC/Lambda-PE/CD19-<br>ECD/CD5-PC5.5/CD45-PC7<br>and B2 CD20-FITC/CD10-<br>PE/CD19-ECD/CD38-<br>PC5.5/CD45-PC7 Monoclonal<br>and Polyclonal Antibody<br>Reagents. | that contain the specific cell<br>surface markers associated with<br>the B-cell lineage. | | The Myeloid Lineage panel | Comprising M CD7-FITC/<br>CD13-PE/CD34-ECD//CD33-<br>PC5.5/CD45-PC7 Monoclonal<br>Antibody Reagents. | For use to identify lymphocytes<br>that contain the specific cell<br>surface markers associated with<br>the Myeloid lineage. | | Accessory Reagents Required | | | | Flow-Check Pro Fluorospheres | Flow-Check Pro Fluorospheres<br>are a suspension of fluorescent<br>microspheres used for daily<br>verification of the optical<br>alignment and fluidics for<br>Forward Scatter (FS) and FL1-<br>FL4 fluorescence parameters. | Instrument Alignment Quality<br>Control Reagent to provide<br>instrument alignment Quality<br>Control instructions. | | Flow-Set Pro Fluorospheres | Flow-Set Pro Fluorospheres are<br>a suspension of fluorescent<br>microspheres used as an aid in<br>standardizing forward scatter,<br>side scatter, and fluorescence<br>detectors on the FC 500 (FL1-<br>FL5). | Auto Setup Reagent for<br>standardization of flow<br>cytometer light scatter and<br>fluorescence intensity<br>instrument settings to provide<br>application-specific instrument<br>target ranges for<br>standardization. | | QuickComp 4 Kit | The QuickComp 4 Kit consists<br>of four single-color fluorescent<br>reagents comprised of one<br>monoclonal antibody each. Each<br>antibody is labeled with one of<br>four fluorochromes, three are<br>utilized for this test: CD45-<br>FITC, CD45-PE, and CD45-<br>ECD. | The QuickComp 4 Kit is used to<br>adjust color compensation<br>settings on a flow cytometer<br>equipped with AutoSetup<br>software, prior to multi-color<br>analysis with FITC, PE, and<br>ECD conjugated monoclonal<br>antibody reagents. | | Color Compensation Reagents | Compensation reagents CD45-<br>PC5.5 and CD45-PC7. | Used to adjust color<br>compensation settings on a flow<br>cytometer with AutoSetup<br>software.<br>Note: Color Compensation<br>Reagents are required. It is<br>recommended to use the<br>reagents with normal whole<br>blood specimens to adjust color<br>compensation settings on a flow<br>cytometer, prior to multi-color<br>analysis. | | IOTest 3 Fixative Solution | The IOTest 3 Fixative Solution, which has a formaldehyde base, specially developed for the fixing of leukocytes. | Leukocyte fixative solution used on all leukocytic preparations to enable leukocytic preparations to be stored for several hours without deterioration after staining with a fluorescent antibody. It is used to fix leukocytes following immunofluorescent staining with the fluorochrome-conjugated antibodies and lysis of the red blood cells. | | Accessory Reagents Recommended but Not Provided | | | | VersaLyse Lysing Solution | Red cell lysing reagent intended for the lysis of red blood cells in the preparation of biological samples for flow cytometry analysis. | VersaLyse is intended for the lysis of red blood cells in the preparation of biological samples for flow cytometry analysis. | | Immutrol Control Cells | Process controls for flow cytometry. | Quality control material assayed for lymphocyte, granulocyte and monocyte specific antigens and single platform absolute counts. The light scatter, population distribution, fluorescence intensity, and antigen density mimic those of normal whole blood. | | StemTrol Control cells | An antibody-to-antigen positive control for CD34 and CD45 staining in flow cytometry studies, consisting of a preserved cell line, BK010044, | Quality control material for CD34 and CD45. |