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    K Number
    K252163
    Device Name
    Elecsys Phospho-Tau (181P) Plasma
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2025-10-08

    (90 days)

    Product Code
    SET
    Regulation Number
    866.5840
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K221842
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Elecsys Phospho-Tau (181P) Plasma is an in vitro electrochemiluminescence immunoassay (ECLIA) intended for the measurement of the phosphorylated Tau 181 protein in human plasma on cobas e immunoassay analyzers.

    The Elecsys Phospho-Tau (181P) Plasma assay result is intended to be used as an aid in the initial assessment for Alzheimer's disease and other causes of cognitive decline in adult patients aged 55 years and older, presenting with signs, symptoms, or complaints of cognitive decline. The result should be interpreted in conjunction with other clinical information.

    A negative test result is consistent with a negative amyloid positron emission tomography (PET) scan result and reduced likelihood that a patient's cognitive impairment is due to amyloid pathology. These patients should be investigated for other causes of cognitive decline.

    A positive test result may not be consistent with a positive amyloid PET scan result. Patients with an initial positive result should be further investigated to determine whether the amyloid pathology can be a cause of cognitive impairment.

    Device Description

    In vitro electrochemiluminescence immunoassay (ECLIA) intended for the measurement of the phosphorylated Tau 181 protein (pTau181p) in human plasma.

    Elecsys Phospho-Tau (181P) Plasma utilizes a sandwich test principle and has a total duration time of 18 minutes.

    • 1st incubation: 30 µL of sample, biotinylated monoclonal antibody specific for phosphorylation at threonine 181, and a monoclonal tau-specific antibody labeled with a ruthenium complex^a) react to form a sandwich complex.
    • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
    • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
    • Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the cobas link.
    AI/ML Overview

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