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510(k) Data Aggregation

    K Number
    K012399
    Device Name
    MODIFICATION TO ELECSYS FSH II CALSET
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2001-08-24

    (28 days)

    Product Code
    JIT
    Regulation Number
    862.1150
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K003409
    Why did this record match?
    Device Name :

    MODIFICATION TO ELECSYS FSH II CALSET

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

    Elecsys FSH II CalSet is used for calibrating the quantitative Elecsys FSH assay on the Elecsys 1010 and 2010 immunoassay and Modular Analytics E170 systems.

    Device Description

    Roche Diagnostics Elecsys FSH II CalSet consists of lyophilized human serum with added human FSH in two concentration ranges.

    AI/ML Overview

    The provided text is a 510(k) summary for the "Elecsys FSH II CalSet" and does not contain information on acceptance criteria or a study proving the device meets those criteria. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

    Therefore, I cannot extract the requested information from the given document. The document describes the device, its intended use, and compares it to a predicate device to claim substantial equivalence, which is the primary purpose of a 510(k) submission. It does not include details on formal acceptance criteria, device performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance assessments.

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