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    K Number
    K042411
    Device Name
    ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
    Manufacturer
    AXIS-SHIELD LTD.
    Date Cleared
    2005-04-07

    (212 days)

    Product Code
    NRP,DLJ,LAS
    Regulation Number
    862.3840
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K034069
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXIS-SHIELD LTD.

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

    The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy.

    The IMx® Sirolimus Calibrators are for the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.

    The IMx® Sirolimus MODE 1 Calibrator is for the adjustment of the stored calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.

    The IMx® Sirolimus Controls are for the verification of the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.

    The IMx Sirolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (whole blood patient specimens, IMx® Sirolimus Calibrators and Controls) to be tested on the IMx® Sirolimus assay.

    Device Description

    Microparticle Enzyme Immunoassay (MEIA) for use on Abbott IMx® system.

    Assay procedure:

    • Incubate the sample with the anti-sirolimus antibody-coated microparticles.
    • Add sirolimus alkaline phosphatase conjugate and incubate.
    • Transfer to matrix cell.
    • Wash to remove unbound substances.
    • Add substrate.
    • Measure fluorescent product.
    AI/ML Overview

    This document describes the performance characteristics and acceptance criteria for the Abbott IMx® Sirolimus Microparticle Enzyme Immunoassay (MEIA) test.

    Here's the breakdown of the information requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (from predicate device or implied by comparison)Reported Device Performance (IMx® Sirolimus MEIA Test)
    PrecisionWithin-run CV of 2.2 - 7.0%; Between-run CV of 2.2 - 9.2% (CEDIA® Sirolimus Test)Total imprecision of ≤ 15% through assay range of 5-22ng/ml
    RecoveryRecovery of 101 - 112% of expected values (CEDIA® Sirolimus Test)Mean recovery across samples of 90 - 110% of expected values.
    Dilution LinearityRecovery of 91 - 106% of expected values for a single high sample (CEDIA® Sirolimus Test)Mean recovery across samples of 99 - 115% of expected values.
    Analytical Sensitivity4.0 ng/mL (CEDIA® Sirolimus Test)≤ 1.5ng/ml
    Functional SensitivityNot listed (CEDIA® Sirolimus Test)≤ 2.5ng/ml
    Specificity for Parent Compound (Cross-reactivity with metabolites)11-hydroxy - 44%; 41-O- and 32-O-Demethyl - 73%; Trihydroxy and 41-O-didemethyl - 14%; 41-desmethyl-hydroxy- 10%; Fraction 2 and 7-O-desmethyl - 8.7%; Isomers of fraction 4 - 22%; Hydroxyl - 7%; N-oxide - 15%; Fraction 6 and isomers of Fraction 7 - 4% (CEDIA® Sirolimus Test)11-hydroxy-sirolimus - 37%; 41-O-demethyl-sirolimus - 58%; 7-O-demethyl-sirolimus - 63%; 41-O-demethyl-hydroxyl-sirolimus - 6%
    Co-Administered Drug Interference
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    K Number
    K001981
    Device Name
    DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
    Manufacturer
    AXIS-SHIELD LTD.
    Date Cleared
    2000-08-21

    (53 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXIS-SHIELD LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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