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510(k) Data Aggregation

    K Number
    K030616
    Device Name
    CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
    Manufacturer
    MICROGENICS CORP.
    Date Cleared
    2003-03-31

    (33 days)

    Product Code
    LAS
    Regulation Number
    862.3280
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5

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

    The CEDIA® Cyclosporine Plus High Range Controls 4 and 5 are in-vitro diagnostic medical devices intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

    Device Description

    Not Found

    AI/ML Overview

    This looks like an FDA clearance letter for an in-vitro diagnostic device, specifically quality control materials. It does not contain the kind of detailed study information you're asking for regarding acceptance criteria, device performance, sample sizes, expert ground truth, or AI-related metrics.

    The document primarily states that the device, CEDIA® Cyclosporine Plus High Range Controls 4 and 5, has been found substantially equivalent to legally marketed predicate devices. It confirms the device's classification and its intended use as an assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

    Therefore, I cannot extract the information you've requested from this document. The typical FDA 510(k) summary (or the full submission if it were available) would contain the details of the studies performed to demonstrate substantial equivalence, including performance data.

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