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    K Number
    K030144
    Device Name
    MODIFICATION TO PENTRA 60 AND PENTRA 60C+
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    2003-01-31

    (16 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Type
    Special
    Panel
    Hematology
    Reference & Predicate Devices
    K961439,K992511,K003677
    Why did this record match?
    Device Name :

    MODIFICATION TO PENTRA 60 AND PENTRA 60C+

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

    The ABX PENTRA 60 and 60C+ Hematology Analyzer are fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

    The ABX PENTRA 60 and 60C+ Hematology Analyzer are able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

    Device Description

    The ABX PENTRA 60 & PENTRA 60C+ are benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source.

    The PENTRA 60 is an standalone device using a keyboard and LCD screen integrated into the device. Whereas the PENTRA 60C+ is the PENTRA 60 connected to a dedicated workstation with user interfacing software.

    AI/ML Overview

    The ABX PENTRA 60 and PENTRA 60C+ Hematology Analyzers underwent a study to demonstrate their performance against pre-defined acceptance criteria, primarily focusing on expanded linearity ranges and maintaining accuracy.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance CriteriaReported Device Performance
    PrecisionIn accordance with EP5-A (NCCLS guidelines)Good precision for all parameters, "entirely acceptable".
    Linearity Range (WBC)Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters."0-120 x 10^3/μL
    Linearity Range (RBC)Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters."0 - 8.0 x 10^5/μL
    Linearity Range (HGB)Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters."0 - 24g/dl
    Linearity Range (HCT)Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters."0 - 67%
    Linearity Range (PLT with Hgb>2g/dl)Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters."0 - 1,900 x 10^3/μL
    **Linearity Range (PLT with Hgb 0.95
    Accuracy (Inter-procedural Correlation for other parameters)Not explicitly stated, but implies historical good correlation from previous submissions.Good correlation demonstrated in previous submissions.
    Carry-over
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