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    K Number
    K150955
    Device Name
    Elecsys Progesterone III Cal Check 5
    Manufacturer
    ROCHE DIAGNOSTICS
    Date Cleared
    2015-05-01

    (22 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Elecsys Progesterone III Cal Check 5

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

    The Elecsys Progesterone III CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

    Device Description

    The Elecsys Progesterone III CalCheck 5 is a lyophilized product consisting of 5 different levels of plant-derived Progesterone in a human serum matrix. It is traceable via ID-GC/MS (isotope dilution gas chromatography mass spectrometry) to highly purified progesterone by weight analogous to BCR-348R and ERM-DA347.

    AI/ML Overview

    The provided text describes the Elecsys Progesterone III CalCheck 5, a control material, and studies conducted to demonstrate its stability. This is not a description of an AI/ML powered device, therefore some of the requested information (e.g. number of experts, adjudication methods, MRMC studies, standalone performance) is not applicable.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criterion (for Stability Studies)Reported Device Performance (as % Recovery or value)
    Study 1: Open-Vial Stability
    CalCheck Level 1:
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