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510(k) Data Aggregation

    K Number
    K141161
    Device Name
    ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)
    Manufacturer
    HORIBA ABX SAS
    Date Cleared
    2014-12-20

    (229 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    k030799,K030799
    Why did this record match?
    Reference Devices :

    K030799

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

    The ABX MICROS ES 60 (OT and CT models) is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories to identify and enumerate the following parameters: WBC, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM%, LYM#, MON%, MON#, GRA%, GRA#, in K2EDTA and K3EDTA anticoagulated venous whole blood samples of adult patient population. It is not intended to be used for pediatric subjects.

    Device Description

    The ABX MICROS ES 60 is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hemoglobin measurement, cell counting, quality control, calibration, and cleaning. The system is a microprocessor controlled hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. It operates in complete blood count (CBC) and Differential (DIFF) mode using a combination of focused flow impedance and light transmission technologies. It is available in Closed (CT) or Open Tube (OT) sampling versions.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Device Performance for ABX Micros ES 60

    1. Table of Acceptance Criteria and Reported Device Performance

    The document provides acceptance criteria for various analytical performance characteristics. Here's a summary:

    Performance CharacteristicMeasurandAcceptance CriteriaReported Device Performance (Summary)
    Limit of Blank (LoB)WBCN/A (implied clinical relevance)$0.1 \times 10^3/mm^3$
    RBCN/A$0.01 \times 10^6/mm^3$
    HCTN/A0.1 %
    PLTN/A$1 \times 10^3/mm^3$
    Limit of Detection (LoD)WBCN/A (implied clinical relevance)$0.2 \times 10^3/mm^3$
    RBCN/A$0.01 \times 10^6/mm^3$
    HGBN/A0.5 g/dL
    HCTN/A0.2 %
    PLTN/A$4 \times 10^3/mm^3$
    Limit of Quantitation (LoQ)WBC% Total-error
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