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510(k) Data Aggregation

    K Number
    K024002
    Device Name
    PENTRA 80
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    2003-01-03

    (30 days)

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

    PENTRA 80

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

    The ABX PENTRA 80 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.

    The ABX PENTRA 80 is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.

    Device Description

    The PENTRA 80 Hematology analyzer is a 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 instrument is microprocessor driven, with an internal PC that performs further data processing and hosts the user interface.

    AI/ML Overview

    The provided text describes the ABX PENTRA 80 Hematology Analyzer and its performance in a 510(k) premarket notification. However, it does not contain a detailed table of acceptance criteria or performance metrics with specific numerical values for a direct comparison. The information is presented in a narrative format, highlighting that the device met certain standards and showed good correlation with a predicate device.

    Here's an attempt to extract the requested information based on the available text:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Implied)Reported Device Performance
    PrecisionAcceptable for all parameters (in accordance with EP5-A NCCLS guidelines)"good precision... and is entirely acceptable for all available parameters." (No specific numerical values provided in the summary, only a general statement of compliance with guidelines.)
    LinearitySupported by clinical dataWBC (0-120 x 10^3/μL), RBC (0 - 8.0 x 10^6/uL), HGB (0 - 24g/dl), HCT (0 - 67%), PLT with Hgb>2g/1 (0 - 1,900 x 10^3/μL), and PLT with Hgb 0.95 with predicate device)
    Leukocyte DifferentiationGood results on differentiation between true & false positives and true & false negatives"provided good results on the differentiation between true & false positives and true & false negatives." (No specific sensitivity, specificity, or accuracy metrics provided.)
    Sample StabilityRelative sample stability over a 48-hour period at 4°C"assures a relative sample stability over a 48 hour period at 4°C."
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