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The COULTER GEN S System with IRF and MRV Parameters is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER GEN-S System also provides automated Reticulocyte analysis. An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.

The Immature Reticulocyte Fraction expresses the number of early reticulocytes as a proportion of the total reticulocyte count. Mean reticulocyte volume (MRV) is the average cell volume of the reticulocytes, determined by the VCS Technology algorithm and is reported in femtoliters (fL). This 510(k) Premarket Notification provides information demonstrating that Coulter hematology analyzers with IRF and MRV parameters are substantially equivalent to products previously cleared for this use. The COULTER hematology analyzers with IRF and MRV parameters are compared to Sysmex™ hematology analyzers with the IRF parameter. The MRV parameter is presented as a discussion of the calculation and supported by precision data from a COULTER GEN-S System analyzer. Unlike the Sysmex R-1000, R-3000 and RAM-1 analyzers which are dedicated to the measurement of reticulocyte parameters, the COULTER hematology analyzers, including the GEN.S, measure multiple CBC and differential parameters in addition to the measurement of reticulocyte parameters.

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 reticONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems combines a reagent kit consisting of a Coriphosphine-O dye and a Biological Calibrator, and software for automated analysis of reticulocytes in whole blood using EPICS® XL™ Flow Cytometry Systems with SYSTEM II™ Software. The system is intended "For In Vitro Diagnostic Use" and allows identification and enumeration of reticulocyte percentage and absolute count. The reticulocyte count is diagnostically useful in discriminating between normal erythropoiesis. It can be useful in the diagnosis or detection of anemal hemorthaging, hemoglobinopathies and certain nutritional or vitamin deficiencies. Decreased or defective red cell production may result in a lower reticulocyte count such as in aplastic anemias. Elevated reticulocyte counts may be observed in clinical conditions where red cell destruction is increased (for example, hemolytic anemias and hypersplenism) or where there is increased red cell production (for example, erythropoietin drug therapy and a response to treated anemia). Since the kidneys are a primary source of erythropoietin (a hormone that regulates erythroid development), the reticulosyte count is also affected in individuals with renal disease. In cases of renal atrophy, the reticulocyte count will be decreased. In cases of malignancy or hypersplenism, the reticulocyte count will be elevated. Reticulocyte counts are also used as an indicator of bone marrow recovery following intensive or a bone marrow transplantation. Increased reticulocyte counts in these patients are indicative of bone marrow regeneration.

The reticONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems combines a reagent kit consisting of a Coriphosphine-O dye and a Biological Calibrator, and software for automated analysis of reticulocytes in whole blood using EPICS® XL™ Flow Cytometry Systems with SYSTEM II™ Software. The system is intended "For In Vitro Diagnostic Use" and allows identification and enumeration of reticulocyte percentage and absolute count.

The tetraONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent 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 EPICS® XL™ flow cytometry systems with SYSTEM II™ Software. The system is intended "For In Vitro Diagnostic Use" and allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+, CD19+, and CD3-/CD56+ lymphocyte population percentages and absolute counts. The system also provides the T4/T8 ratio when using CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent, and total lymphocyte percentage when using CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent. CD3+, CD4+, CD8+, and/or CD19+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocyte levels following organ transplantation. To illustrate, identification of abnormal levels of CD3+, CD4+, CD8+, and/or CD19+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with altered white blood cell counts. Altered percentages of CD3+, CD4+, CD8+, and/or CD19+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T (CD3+, CD4+, CD8+) and/or B (CD19+) lymphocyte measurements may be useful as aids in monitoring these cellular populations. Identification of abnormal levels of CD4+ immunodeficiency might also aid in the diagnosis of immunodeficiency disease. For example, infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS), results in profound immunosuppression due predominantly to a selective of the CD4+ lymphocytes that express the receptor for the virus, which is associated with the CD4+ antigen. Progressive clinical and immunologic deterioration generally correlated with a falling CD4+ lymphocyte count. NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytotoxicity against targets such as certain tumor and virus-infected cells. CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. Used as a four color Lymphocyte Immunophenotyping Panel, CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 also function as a quality control check for a specimen in terms of CD3+ lymphocyte measurement reproducibility within the Panel.

The tetraONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems with CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent 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 EPICS® XL™ flow cytometry systems with SYSTEM II™ Software.

The COULTER® AC T diff 2m analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.

The COULTER® Ac·T diff 2™ Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. COULTER® Ac.T diff 2™ Analyzer has the same technological characteristics and is substantially equivalent to the COULTER® COUNTER® S-PLUS IV and LYSE S PLUS D (also called COULTER COUNTER® Model S PLUS IV with Three Population Differential and Model S PLUS IV Diff), which was cleared by 510(k) K823355 on Dec. 28, 1982 and is a modified version of the COULTER® Ac-T diff ™ Analyzer which were cleared by 510(k) K973634 on October 29, 1997. As with the predicate devices, the COULTER® Ac-T diff 2™ Analyzer utilizes the Coulter principle for the enumeration and sizing of blood cells, in combination with an automatic diluting and mixing device for sample processing and a single beam photometer for the measurement of hemoglobin. The same reagent system, composed of an isotonic diluent, lyitc reagent to lyse red blood cells for WBC and hemoglobin measurement and instrument cleaner, is used on Model S PLUS IV Diff and Ac-T diff Analyzers. All the devices determine the following CBC parameters: WBC, LY #, LY%, MO #, MO %, GR #, GR %, RBC, Hgb, Hct, MCV, MCH, MCHC, Plt, RDW, MPV. Pct* and PDW* are also measured. *These parameters are not for diagnostic use but can be used as internal instrument checks on the platelet parameters. Like the Ac T diff Analyzer, the Ac T diff 2 can analyze samples in either of two modes: whole blood and pre-dilute. Additionally, the Ac-T diff 2 can sample closed vial specimens by virtue of a rotary cap piercing functionality. The MODEL S PLUS IV Diff does not have a pre-dilute mode or a closed vial sampling mode.

IMMUNO-TROL™ Control Cells (Immuno-Trol) is an for an assayed, lysable whole blood quality control product for immunophenotyping analysis using monoclonal antibody reagents and flow cytomerry. It provides a positive cell control that is processed in the same manner as a whole blood sample. This allows verification of reagent performance and the methods used for staining targeted cells, lysing erythrocytes, and analyzing samples by flow cytometry. CD populations intended "For In Vitro Diagnostic Use" and those intended "For Research Use In Diagnostic Procedures." are given in separate tables in the TABLE OF EXPECTED RESULTS section of the Immuno-Trol package insert. Immunophenotyping analysis by flow cytometry involves the identification and enumeration of targeted cells in whole blood samples. Whole blood samples are stained with monoclonal antibodies and erythrocytes are lysed prior to flow cytometric analysis. A positive cell control is required to verify reagent performance, sample performance, sample preparation methods, and staining procedures. A positive cell control should mimic a representative whole blood sample in terms of monoclonal antibody performance, erythrocyte lysing, and flow cytometric analysis.

IMMUNO-TROL™ Control Cells (Immuno-Trol) is an 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.

CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification of total CD3+ and CD19+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITCMsIgG1-PCS, is used to monitor nonspecific staining. CYTO-STAT® triCHROME™ CD45-FITCMsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two MsIgG1 subclass monoclonal antibodies conjugated to RD1 and PC5. CD3+ and/or CD19+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocyte levels following organ transplantation. To illustrate, identification of abnormal levels of CD3+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ and/or CD19+ lymphocytes, in conjunction with CD4+ (inducer) and CD8+ (suppressor/cytotoxic) T lymphocytes and corresponding T4/T8 ratios, may aid in the diagnosis and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, hear, liver, lung) transplantation suggests T and/or B Jymphocyte quantitation may be useful as an aid in monitoring these cellular populations. As part of a Three Color Lymphocyte Immunophenotyping Panel which includes the NK (Natural Killer) lymphocyte reagent, CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PCS, CYTO-STAT® triCHROME™ CD45-FITC/CD19-RDI/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T. B and NK. The reagent also functions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.

CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD19+ lymphocytes in whole blood by flow cytometry. An isotypic control. CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RD1/MsIgG1-PC5, is used to monitor nonspecific staining. CYTO-STAT® triCHROME CD45-FITC/MsIgG1-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two monoclonal antibodies of the MsIgG1 subclass conjugated to RD1 and PC5.

CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 Monoclonal Antibody Reagent is a three-color fluorescent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-PC5, is used to monitor nonspecific staining. CYTO-STAT® triCHROME™ CD45-FITCMsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluoresent reagent comprised of three murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two MsIgG1 subclass monoclonal antibodies conjugated to RD1 and PC5. CD3+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocvte levels following organ transplantation. To illustrate, identification of abnormal levels of CD3+ lymphocytes may aid in the diagnosis and/or progrosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ lymphocytes, in conjunction with CD4+ (induce) and CD8+ (suppressor/cytoxic) T lymphocytes and corresponding T478 ratios, may aid in the diagnois and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HIV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T lymphocyte quantitation may be useful as an aid in monitoring these cellular populations. NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytoxicity against targets such as certain tumor and virus-infected cells. As part of a Three Color Lymphocyte Immunophenotyping Panel which includes the B lymphocyte reagent, CYTO-STAT® triCHROME™ CD45-FITC/CD19-RD1/CD3-PC5, CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. The reagent also functions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.

CYTO-STAT® triCHROME™ CD45-FITC/CD56-RD1/CD3-PC5 is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-. CYTO-STAT® triCHROME™ CD45-FITC/MsIgG1-RD1/MsIgG1-PC5 Isotypic Control is a three-color fluorescent reagent comprised of three murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® triCHROME™ Monoclonal Antibody Reagents comprised of CD45-FITC and two monoclonal antibodies conjugated to RD1 and PC5.

CYTO-STAT® CD3-FITC/CD56-RD1 Monoclonal Antibody Reagent is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-/CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT®/COULTER CLONE® MslgG1-RD1/MsIgG1-FITC, is used to monitor nonspecific staining. CYTO-STAT®COULTER CLONE® MsIgG1-RD1/MsJgG1-PC5 Isotypic Control is a two-color fluorescent reagent comprised of two murine monoclonal antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® or CYTO-STAT®/COULTER CLONE® Monoclonal Antibody Reagents comprised of two MsIgGl subclass monoclonal antibodies conjugated to RD1 and FITC. CD3+ lymphocyte percentages and absolute counts may be used as aids to evaluate immune competency underlying known or unknown disease states and to monitor lymphocyte levels following organ transplantation. To illustrate, identification of abnormal levels of CD3+ lymphocytes may aid in the diagnosis and/or prognosis of unidentified disease conditions in patients with low white blood cell counts. Measurement of CD3+ lymphocytes, in conjunction with CD4+ (inducer) and CD8+ (suppressor/cytotoxic) T lymphocytes and corresponding T4T8 ratios, may aid in the diagnosis and/or prognosis of immunodeficiency disease such as infection with human immunodeficiency virus (HV), the etiologic agent of acquired immunodeficiency syndrome (AIDS). Altered percentages of CD3+ lymphocytes recorded following organ (for example, kidney, heart, liver, lung) transplantation suggests T lymphocyte quantitation may be useful as an aid in monitoring these cellular populations. NK (Natural Killer) lymphocyte populations have been functionally defined as a lymphocyte population capable of mediating non-MHC restricted cytoxicity against targets such as certain tumor and virus-infected cells. As part of a Two Color Lymphocyte Immunophenotyping Panel which includes the B lymphocyte reagent, CYTO-STAT®/COULTER® CLONE® CD3(IgG1)-FITC/B4-RD1, CYTO-STAT® CD3-FITC/CD56-RD1 provides the ability to comprehensively identify and enumerate an individual's major lymphocyte subsets: T, B and NK. The reagent also finctions as a quality control check for a specimen in terms of total lymphocyte percentage and CD3+ lymphocyte measurements across the panel.

CYTO-STAT® CD3-FITC/CD56-RD1 is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. The reagent allows simultaneous identification and enumeration of total CD3+ and CD3-/CD56+ lymphocytes in whole blood by flow cytometry. An isotypic control, CYTO-STAT®/COULTER® CLONE® MsIgG1-RD1/MsIgG1-FITC, is used to monitor nonspecific staining. CYTO-STAT®/COULTER® CLONE® MsIgG1-RD1/MsIgG1-FITC is a two-color fluorescent reagent comprised of two murine monoclonal antibodies. Each antibody is labeled with a different color fluorochrome. This product is intended for use as a quality control reagent to monitor the levels of nonspecific antibody binding in cell surface staining procedures which use CYTO-STAT® OR CYTO-STAT®/COULTER® CLONE® Monoclonal Antibody Reagents comprised of two monoclonal antibodies of the MsIgG1 subclass conjugated to RD1 and FITC.

The COULTER® AC-T diff™ analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories.

The product is a hematology Automated Differential Cell Counter which like the predicate devices, COULTER A C T Series Analyzer and COULTER COUNTER S-PLUS IV and LYSE S PLUS D, uses the Coulter method of impedance measurement for particle counting and sizing. Blood cells passing through a small opening simultaneously with an electric current cause an impedance change in the orifice. This electrical pulse can be sized and counted. While the number of pulses indicates the particle count, the size of the electrical pulse is proportional to cell volume. Under the controlled condition of lysis, a chemical reaction demonstrates three distinct populations of leukocytes: lymphocytes, mononuclear cells and granulocytes. The percentage of leukocytes that fall into each of the three categories is derived from the WBC histogram: the LY area is approximately from 35 fL to 90 fL, the MO area is approximately from 90 fL to 160 fL and the GR area is approximately from 160 fL. The COULTER® AC T diff™ Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER® AC T diff analyzer has the same intended use as the predicate devices. Both the A.T diff and the predicate devices utilize the Coulter principle for cell counting and sizing in combination with automatic diluting and mixing for sample processing and a beam photometer for hemoglobinometry. The same reagent system, consisting of isotonic diluent, lytic reagent, and cleaning agent, is used on the AS.T diff analyzers and the predicate devices. The ACT diff analyzers and the predicate devices have the ability to print and transmit results if the instrument has been setup to do so. The COULTER AC T diff Analyzer is the same device as the COULTER AS T Series Analyzers except for the modifications required for the measurement of a three-part leukocyte differential, RDW, and MPV, automated calibration and quality control evaluation, patient storage and selectable print profiles.