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    K Number
    K150815
    Device Name
    BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2015-12-17

    (265 days)

    Product Code
    PMG,GKL,JPK,OYE
    Regulation Number
    864.5220
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K981761,K071141,K961610,K982231
    Why did this record match?
    Device Name :

    BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BD FACSPresto System:
    The BD FACSPresto System is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer to be used in conjunction with single use reagent cartridges in performing the direct cell enumeration and measurement of absorbance spectrums.
    · For use with the BD FACSPresto™ CD4/Hb Cartridge and BD FACSPresto™ CD4/Hb Cartridge Kit in the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
    · For use in children, adolescents, and adults.
    · For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes.
    · Not for point-of-care use.
    · For in vitro diagnostic use.

    BD FACSPresto CD4/Hb Cartridge & BD FACSPresto CD4/Hb Cartridge Kit:
    The BD FACSPresto CD4/Hb Cartridge is a single use reagent cartridge to be used with the BD FACSPresto™ System for performing the direct quantification and enumeration of CD4 absolute count, CD4 percentage of lymphocytes, and determination of hemoglobin concentration in normal and HIV positive patients, in conjunction with other laboratory and clinical findings.
    · For use in children, adolescents, and adults
    · For use with human whole blood from fingerstick and/or venous collections in K2 EDTA blood collection tubes.
    · Not for point-of-care use.
    · For in vitro diagnostic use.

    BD Multi-Check Control:
    The BD™ Multi-Check control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and performance, and data analysis.
    The BDTM Multi-Check control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.

    BD Multi-Check CD4 Low Control:
    The BD™ Multi-Check CD4 low control is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, red blood cell (RBC) lysis, instrument setup and data analysis.
    The BD™ Multi-Check CD4 low control is also intended as a CD4 and %CD4 process control for antibody staining, instrument performance, and data analysis on the BD FACSPresto™ system, an imaging cytometer.

    Eurotrol FACSPresto Hb Control:
    Eurotrol FACSPresto Hb Control is an assayed hemoglobin control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPrestoTM System.

    Device Description

    The BD FACSPresto System is an accurate, robust, and portable CD4, %CD4, and hemoglobin (Hb) System. The BD FACSPresto System has fluorescence microscopy and light absorbance capabilities. In addition, the instrument has integrated BD FACSPresto Software and instrument quality controls.
    The BD FACSPresto CD4/Hb Cartridge contains antibody-fluorophore conjugates dried on a reagent disc and is embedded with reagent quality controls. The cartridge is designed with onboard reagents that mix well into the blood sample, and enumerate cells populations using fluorescence only. The cartridge is designed with fluidic properties that distribute a sufficient volume and sample into the imaging field of view for precise cell counting.
    The BD FACSPresto CD4 and %CD4 assays are designed to stain cells with antibody-fluorophore conjugates for three color fluorescence reading using the BD FACSPresto System. CD4 PE-Cy5 stains CD4-positive cells; while CD3-APC and CD45RA-APC stains total lymphocytes for use in the %CD4 calculation (CD3 stains T cells, while CD45RA stains B and NK cells in a patented formulation). CD14-PE is used for staining monocytes to exclude CD4 and/or CD45RA expressing monocytes from analysis.
    BD Multi-Check Control and BD Multi-Check CD4 Low Control are process controls for the CD4 and %CD4 assay on the BD FACSPresto system. They are composed of human leukocytes and erythrocytes in a stabilizing medium and are intended to be used as a complete process control for antibody staining. instrument performance, and data analysis on the BD FACSPresto system.
    The BD FACSPresto Hb assay is performed by a spectrophotometric method. using absorbance at an isobestic point for multiple forms of hemoglobin, with correction for scatter. The cartridge microfluidic channel permits absorbance reading of blood and of a reference area.
    Eurotrol FACSPresto Hb Control is used as a process control for the Hb assay on the BD FACSPresto system. It is composed of purified bovine hemolysate and is intended to be used as an assayed hemoglobin process control intended for in vitro diagnostic use in the verification of the precision and accuracy of the BD FACSPresto System.

    AI/ML Overview

    Here is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Device Performance for BD FACSPresto System

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are generally described as meeting CLSI document standards and "study acceptance criteria" or "acceptable results." Specific quantitative targets are less frequently provided in this summary but are indicated as having been met.

    Performance CharacteristicAcceptance Criteria (Implicit from "Standard" or "Results")Reported Device Performance
    Method Comparison (CD4 & %CD4)Substantially equivalent to predicate system (BD FACSCalibur).BD FACSPresto provided CD4 and %CD4 results that are substantially equivalent to the predicate system.
    Method Comparison (Hb)Substantially equivalent to reference system (Sysmex KX-21N).BD FACSPresto provided Hb results that are substantially equivalent to the reference system.
    Precision (BD FACSPresto - Bench)Acceptable CV and/or SD results for within-run and total precision.Acceptable CV and/or SD results reported for within-run and total precision for CD4, %CD4, and Hb using controls.
    Linearity (BD FACSPresto - Bench)Acceptable linearity for CD4, Lymphocyte, and Hb ranges.Acceptable linearity demonstrated: CD4 (42-4872 cells/µL), Lymphocyte (124-10,713 cells/µL), Hb (2-26 g/dL).
    Hemoglobin Assay TraceabilityHb assay traceable to HiCN method, linear and accurate (2-20 g/dL).Hb assay is traceable to the HiCN method and is linear and accurate across the reported linear range (2-20 g/dL).
    Analytical Sensitivity (CD4 LoD/LoQ)LoD below claimed range; LoQ established.LoD: 22 cells/uL, LoQ: 35 cells/uL (LoD below system's claimed range).
    Analytical Sensitivity (Hb LoD/LoQ)LoQ supports claimed range of 2-20 g/dL.LoD: 0.91 g/dL, LoQ: 2 g/dL (supports claimed range).
    InterferenceNo clinically significant interference; bias
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