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    K Number
    K050719
    Device Name
    ABX PENTRA DX 120: OPTION SPS EVOLUTION
    Manufacturer
    HORIBA ABX
    Date Cleared
    2005-04-26

    (36 days)

    Product Code
    GKZ,GKJ,KPA
    Regulation Number
    864.5220
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K961439,K992875,K962633,K990311,K991839,K022200
    Why did this record match?
    Device Name :

    ABX PENTRA DX 120: OPTION SPS EVOLUTION

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

    The ABX PENTRA DX 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET), and nucleated red blood cell count (NRBC) for the in vitro diagnostic use in clinical laboratories.

    The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.

    The option of the SPS Evolution (Slide Preparation System) smears and stains on a clean microscope slide.

    Device Description

    The PENTRA DX 120 Automated Hematology Analyzer is a bench-top, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leukocyte differential count, reticulocyte and NRBC count using principles of cytochemistry, focused flow impedance, light absorbance and fluorescence. The instrument is microprocessor driven.

    Controlled by the PENTRA 120 the optional device SPS Evolution (Slide Preparation System) smears and stains the slides.

    AI/ML Overview

    The provided text describes the ABX PENTRA DX 120 Hematology Analyzer and its associated SPS Evolution (Slide Preparation System). Here's a breakdown of the acceptance criteria and study information, based only on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance (NRBC Parameter)

    The text focuses primarily on the Nucleated Red Blood Cell (NRBC) parameter as the new feature and provides limited, high-level performance statements rather than specific numerical acceptance criteria.

    Performance MetricAcceptance Criteria (Implicit/General Statement)Reported Device Performance
    Precision (NRBC)"good precision in accordance with EP5-A (NCCLS guidelines)""good precision ... and is entirely acceptable for the NRBC"
    Linearity (NRBC/100 WBC Count)"linearity limits claim... are entirely supported""entirely supported by the clinical data provided in this submission."
    Accuracy (Inter-procedural Correlation - NRBC)No specific numerical criteria stated, but implied to show no significant bias."showed no evidence of significant bias between the HoribaABX PENTRA DX 120 and the Abbott CD 4000, Sysmex XE-2100, and multiparameter flow cytometry with r^2 ranging between 0.96 - 0.98."
    Differentiation (True/False Positives/Negatives - NRBC)Implied to be comparable to predicate systems."provided good results on the differentiation between true & false positives and true & false negatives, comparable to other predicate systems."
    Sample Stability (NRBC)Implied to assure relative sample stability over 24 hours."assures a relative sample stability over a 24 hour period at both room temperature and 4°C."
    Carry Over (NRBC)Implied to be less than 1%."supporting a Carry Over claim of
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