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    K Number
    K140436
    Device Name
    ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
    Manufacturer
    FUJIREBIO DIAGNOSTICS, INC.
    Date Cleared
    2014-12-23

    (305 days)

    Product Code
    OSX,JIT,JJX
    Regulation Number
    862.1117
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k093758
    Why did this record match?
    Device Name :

    ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS

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

    Reagent Kit:

    The ARCHITECT Galectin-3 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of galectin-3 in human serum and EDTA plasma.

    The ARCHITECT Galectin-3 assay may be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure (HF). The ARCHITECT Galectin-3 assay is used with the ARCHITECT i System with STAT protocol capability.

    Calibrators:

    The ARCHITECT Galectin-3 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of galectin-3 in human serum and EDTA plasma.

    Controls:

    The ARCHITECT Galectin-3 Controls are for the verification of the ARCHITECT i System when used for the quantitative determination of galectin-3 in human serum and EDTA plasma.

    Device Description

    The ARCHITECT Galectin-3 assay is a two-step immunoassay for the guantitative determination of galectin-3 in human serum or EDTA plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex.

    In the first step, sample and M3/38 anti-galectin-3 coated paramagnetic microparticles are combined. Galectin-3 present in the sample binds to the anti-galecin-3 coated microparticles. After washing, 87B5 anti-galectin-3 acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs).

    A direct relationship exists between the amount of galectin-3 in the sample and the RLUs detected by the ARCHITECT i System optics. The kit is composed of the following:

    ARCHITECT Galectin-3 Reagent Kit (5P03)
    ARCHITECT Galectin-3 Calibrators (5P03-01)
    ARCHITECT Galectin-3 Controls (5P03-10)

    AI/ML Overview

    Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria (from text)Reported Device Performance (from text)
    Precision≤ 10% Total CV for samples 4.0 to 114.0 ng/mLTotal precision for one lot: ≤ 5.8% for all samples. Total reproducibility for two lots: ≤ 4.7% for all samples. (Meets criteria)
    Linearity/Reportable RangeBased on +/-10% deviation from linearity (%DL)Linear range: 5.5 to 103.1 ng/mL. (Meets criteria)
    Detection Limit (LoQ)≤ 4.0 ng/mLLoB: 1.0 ng/mL; LoD: 1.1 ng/mL; LoQ: 2.8 ng/mL. (Meets criteria, as LoQ is ≤ 4.0 ng/mL)
    Analytical SpecificityPercent cross-reactivity with other human recombinant galectin and collagen proteins 17.8 ng/mL), compared with galectin-3 levels in the low risk category ( 17.8 ng/mL) = 1.753 (95% CI: 1.265 – 2.427), which is statistically significant (p-value implicitly
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