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510(k) Data Aggregation

    K Number
    K083260
    Device Name
    ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2009-10-16

    (345 days)

    Product Code
    DDR
    Regulation Number
    866.5680
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN

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

    Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.

    Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.

    Device Description

    The Elecsys Myoglobin Immunoassay includes two applications of the same reagents with different incubation times of 18 minutes (Myoglobin assay) and 9 minutes (Myoglobin STAT assay). The assay is a two-step sandwich immunoassay, using two different monoclonal antibodies directed against human Myoglobin, with streptavidin microparticles, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.

    AI/ML Overview

    The acceptance criteria for the Elecsys Myoglobin Immunoassay and Elecsys Myoglobin STAT Immunoassay, along with the reported device performance, are detailed below. The study proves the device's substantial equivalence to a predicate device (Elecsys Myoglobin STAT assay K983176), rather than establishing new clinical effectiveness. Therefore, the information regarding multi-reader multi-case studies, expert adjudication, and detailed ground truth establishment for novel device performance is not fully applicable in the context of a 510(k) submission for substantial equivalence based on performance characteristics.

    1. Table of Acceptance Criteria and the Reported Device Performance

    FeatureAcceptance Criteria (Predicate: Elecsys Myoglobin STAT assay K983176 Performance)Reported Device Performance (Elecsys Myoglobin and Myoglobin STAT)
    Measuring Range15-3000 ng/mL21-3000 ng/mL
    Expected values (Men)
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