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510(k) Data Aggregation

    K Number
    K992981
    Device Name
    ELECSYS ESTRADIOL CALSET II
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    1999-09-24

    (21 days)

    Product Code
    JIT
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K965109
    Why did this record match?
    Device Name :

    ELECSYS ESTRADIOL CALSET II

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

    For the calibration of the quantitative estradiol assay on the Elecsys 1010 and 2010 immunoassay systems.

    Device Description

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

    AI/ML Overview

    The provided text describes a 510(k) summary for the "Elecsys® Estradiol CalSet II" but does not contain information about acceptance criteria or a study proving that the device meets such criteria.

    The document focuses on:

    • Introduction to the device: Elecsys® Estradiol CalSet II, an in vitro diagnostic calibrator.
    • Intended Use: For the calibration of the quantitative estradiol assay on the Elecsys® 1010 and 2010 immunoassay systems.
    • Substantial Equivalence: A comparison to a predicate device (Elecsys® Estradiol CalSet) outlining similarities (intended use, two levels) and differences (format, matrix, stability).
    • FDA Clearance: The letter from the FDA granting clearance based on substantial equivalence.

    Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets the acceptance criteria from the given text.

    The document is a regulatory submission for device clearance, not a performance study report with acceptance criteria.

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