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510(k) Data Aggregation

    K Number
    K243500
    Device Name
    ARCHITECT iGentamicin
    Manufacturer
    Abbott Laboratories
    Date Cleared
    2025-07-09

    (239 days)

    Product Code
    LCD
    Regulation Number
    862.3450
    Type
    Special
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ARCHITECT iGentamicin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on the ARCHITECT iSystem with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

    Device Description

    The ARCHITECT iGentamicin Reagent Kit contains:

    • Microparticles: 1 bottle (7.11 mL per 100 test cartridge). Anti-gentamicin (mouse, monoclonal) coated microparticles in TRIS buffer with protein (bovine) stabilizer. Minimum concentration: 0.13% solids. Preservatives: ProClin 950 and sodium azide.

    • Conjugate: 1 bottle (11.75 mL per 100 test cartridge). Gentamicin acridinium-labeled conjugate in MES buffer. Minimum concentration: 3 nM. Preservative: ProClin 300.

    AI/ML Overview

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