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    K Number
    K024116
    Device Name
    WIENER LAB. BILIRUBINA DIRECT AA
    Manufacturer
    WIENER LABORATORIES S.A.I.C.
    Date Cleared
    2003-02-12

    (61 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WIENER LAB. BILIRUBINA DIRECT AA

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

    The "Wiener lab. Bilirrubina directa AA" test system is a quantitative in vitro diagnostic device intended to be used in the determination of direct bilirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver. hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

    Device Description

    Direct bilirubin is measured using a stable dichlorophenyldiazonium salt (DPD) to form a red azocompound in an acid solution, with maximal O.D. at 546 nm. The amount of direct bilirubin is determined by measuring the absorbance of this pigment.

    AI/ML Overview

    The provided text describes a 510(k) summary for the "WIENER LAB. BILIRRUBINA DIRECTA AA" test system, which is a quantitative in vitro diagnostic device for determining direct bilirubin in human sera and heparinized plasmas. The summary claims substantial equivalence to a predicate device, the DMA Direct Bilirubin Plus test system.

    The document does not describe an acceptance criteria study in the way one would typically find for a medical device that uses algorithms or AI. This is a traditional in vitro diagnostic device (IVD) based on chemical reactions and spectrophotometric measurements, not an AI/ML powered device. Therefore, many of the requested categories in the prompt are not applicable.

    However, I can extract the performance characteristics that serve as the "acceptance criteria" for chemical assays, by comparing them to a predicate device for demonstrating substantial equivalence. The "study" proving the device meets these criteria is an internal validation performed by Wiener Laboratorios S.A.I.C. for submission to the FDA.

    Here is the information based on the provided text, with explanations for non-applicable categories:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by claiming substantial equivalence to the predicate device (DMA Direct Bilirubin Plus test system). The "reported device performance" are the values for the Wiener Lab. system.

    Performance MetricPredicate Device (DMA Test System) (Implied Acceptance Standard)Wiener Lab. Test System (Reported Performance)
    Intended UseDetermination of direct bilirubin in human serum.Determination of direct bilirubin in human serum and heparinized plasma.
    Test PrincipleConjugated bilirubin reacts with diazotized sulfanilic acid.Direct bilirubin measured using stable dichlorophenyldiazonium salt (DPD).
    Wavelength of Reading550 nmSpectrophotometer: 546 nm; Photocolorimeter: 520-550 nm
    Linearity12 mg/dl14 mg/dl
    Expected Values(Not specified)0.0 – 0.2 mg/dl
    Within-run precision (Normal Level Serum)CV =
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