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510(k) Data Aggregation

    K Number
    K040245
    Date Cleared
    2004-03-24

    (50 days)

    Product Code
    Regulation Number
    862.1150
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)

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

    The C.f.a.s. PAC is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

    Device Description

    The C.f.a.s. PAC is a lyophilized product consisting of human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device called "C.f.a.s. PAC," which is a calibrator for automated systems. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement that you requested.

    The document states under "Performance Characteristics":

    • "The C.f.a.s. PAC was evaluated for value assignment and stability."

    This phrase indicates that a study was performed, but the results, methodology, acceptance criteria, and other specifics of that study are not included in this summary. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study report.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information (Table of acceptance criteria and reported performance, sample sizes, data provenance, number and qualifications of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and training ground truth establishment) is not present in this document.

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