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510(k) Data Aggregation

    K Number
    K042362
    Device Name
    MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2004-12-27

    (118 days)

    Product Code
    KHS
    Regulation Number
    862.1160
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12

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

    For the quantitative determination of carbon dioxide in serum and plasma. For IN VITRO diagnostic use.

    Device Description

    The DCL Carbon Dioxide L3K® assay is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NADH analog (3), which is easy to use and applicable to routine laboratory instrumentation.

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a Carbon Dioxide-L3K Assay. It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory requirements.

    This document does not contain information about:

    • Acceptance criteria and reported device performance in a table format.
    • Sample sizes, data provenance, or details about test sets.
    • Number and qualifications of experts for ground truth establishment.
    • Adjudication methods.
    • Results of multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Sample size for the training set or how ground truth for the training set was established.

    Therefore, I cannot fulfill your request based on the provided input.

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