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510(k) Data Aggregation

    K Number
    K060318
    Device Name
    HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
    Manufacturer
    HORIBA ABX
    Date Cleared
    2006-08-08

    (181 days)

    Product Code
    CIT,JIX,JJY
    Regulation Number
    862.1100
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K052007,K801118
    Why did this record match?
    Device Name :

    HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

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

    Hepatic Enzymes reagents, with associated calibrators and controls, are intended for Hopano Enlighted Chemistry Analyzer to measure a variety of analytes.

    ABX PENTRA AST CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of aspartate aminotransferase in human serum and plasma based on a UV test using L-aspartate and 2-oxoglutarate. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

    The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.

    The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

    The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

    Device Description

    All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

    The ABX PENTRA 400 offers both Closed and Open channels for a multitude of parameters (clinical chemistry, DAT, TDM, plasma protein, hemostasis, optional ISE module).

    All reagents described in this submission are for the quantitative in-vitro determination of their respective parameters

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the ABX PENTRA AST CP reagent, ABX PENTRA Multical, ABX PENTRA N Control, and ABX PENTRA P Control, as derived from the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Explicit or Implied)Reported Device Performance
    ABX PENTRA AST CP (Reagent)
    Sample TypeCompatibility with human serum and plasmaSerum & plasma
    Detection LimitImplied to be clinically acceptable for AST measurement, and at least as good as predicate device4 U/l
    Accuracy and PrecisionImplied to be clinically acceptable and comparable to predicate device. Specifically, for precision, a total CV below a certain threshold would be desired.CV Total
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