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510(k) Data Aggregation

    K Number
    K080607
    Device Name
    CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2008-05-12

    (69 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160

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

    Calibrator for automated systems (C.f.a.s.) Proteins is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.

    Device Description

    Calibrator for automated systems (C.f.a.s.) Proteins

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "Calibrator for automated systems (C.f.a.s.) Proteins." This document is a regulatory approval letter and does not contain the detailed information about acceptance criteria or a study that proves the device meets specific performance metrics.

    Therefore, I cannot provide the requested information. The letter confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not include the results of performance studies, sample sizes, expert qualifications, or ground truth establishment.

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