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510(k) Data Aggregation

    K Number
    K070146
    Device Name
    ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
    Manufacturer
    HORIBA ABX
    Date Cleared
    2007-10-12

    (269 days)

    Product Code
    CDQ,JJY,URI
    Regulation Number
    862.1770
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K052007,K060205,K971477,K070249
    Why did this record match?
    Device Name :

    ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP

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

    ABX PENTRA Urea CP reagent with associated calibrators and controls are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and qlutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

    The ABX PENTRA Urine Control L/H 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 Urea CP is an in vitro diagnostic assay for the quantitative determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum, plasma and urine based on an enzymatic UV test using urease and glutamate dehydrogenase. It is composed of a bi-reagent cassette, with 60 ml and 15 ml compartments. Reagents are chemical solutions with additives.

    The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annex, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control level is provided in one vial of 10 ml.

    AI/ML Overview

    The provided 510(k) summary describes the acceptance criteria and performance study for the ABX PENTRA Urea CP reagent (for urine samples) and ABX PENTRA Urine Control L/H.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Device: ABX PENTRA Urea CP (for urine samples)

    Acceptance CriteriaReported Device Performance
    Detection LimitUrea: 12.6 mmol/l
    BUN: 35 mg/dl
    Accuracy and PrecisionCV Total
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