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    K Number
    K131037
    Device Name
    LIAISON XL HCG
    Manufacturer
    DIASORIN, INC.
    Date Cleared
    2013-09-06

    (144 days)

    Product Code
    DHA
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K003178
    Why did this record match?
    Device Name :

    LIAISON XL HCG

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

    The DiaSorin LIAISON® XL HCG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the quantitative determination of total human chorionic gonadotropin (hCG and ßhCG) in human serum for early detection of pregnancy. Total hCG is the measurement of intact and beta-hCG.

    Device Description

    The method for the quantitative determination of hCG is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer.

    During the first incubation, hCG present in calibrators, samples or controls binds to the solid phase monoclonal antibody, and subsequently after a washing step in a second incubation the antibody conjugate reacts with hCG already bound to the solid phase.

    Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU, relative light units) and is directly related to hCG concentration present in calibrators, samples or controls.

    AI/ML Overview

    Here's an analysis of the DiaSorin LIAISON® XL HCG Premarket Notification (K131037) based on the provided text, focusing on acceptance criteria and study details:

    Acceptance Criteria and Device Performance for DiaSorin LIAISON® XL HCG

    The DiaSorin LIAISON® XL HCG assay is a chemiluminescent immunoassay (CLIA) for the quantitative determination of total human chorionic gonadotropin (hCG and βhCG) in human serum for early detection of pregnancy. The submission aims to demonstrate substantial equivalence to the Roche ELECSYS® HCG +Beta Test (K003178).

    The document details several performance studies to support the device's claims.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state "acceptance criteria" as pass/fail thresholds for each performance characteristic. Instead, it reports the results of the performance studies which implicitly serve as the basis for demonstrating substantial equivalence. For the purpose of this analysis, I will infer the intended acceptance of "good performance" based on the reported values and comparison to the predicate where applicable.

    Performance CharacteristicImplicit Acceptance Criteria (or Reference)Reported Device Performance (DiaSorin LIAISON® XL HCG)
    Method ComparisonGood correlation with predicate devicey = 0.973x - 0.2233; R² = 0.9933 (vs. predicate)
    Reference RangeClearly defined ranges for non-pregnant populations- Premenopausal (
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