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510(k) Data Aggregation

    K Number
    K012668
    Device Name
    RAICHEM GLUCOSE UV REAGENT
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2001-10-15

    (63 days)

    Product Code
    CFR
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RAICHEM GLUCOSE UV REAGENT

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

    This reagent is for the quantitative enzymatic determination of glucose in serum or plasma. For in vitro diagnostic use only.

    Device Description

    Raichem® Glucose UV Reagent

    AI/ML Overview

    Regrettably, without further context from the 510(k) submission for the Raichem® Glucose UV Reagent (K012668), I am unable to describe the acceptance criteria and the study that proves the device meets them.

    The provided text is an FDA clearance letter for the device, which confirms substantial equivalence to a predicate device but does not detail the specific performance studies, acceptance criteria, or their results.

    To answer your request, I would need access to the actual 510(k) summary or the full submission, which would typically contain:

    1. A performance study section: This would outline the design of the study, the chosen acceptance criteria, and the results obtained for accuracy, precision, linearity, etc.
    2. Details on sample sizes and provenance.
    3. Information on ground truth establishment and experts used.
    4. Information on standalone performance.

    Without this information, I cannot provide the requested table or descriptions. The provided document only confirms the regulatory clearance based on substantial equivalence.

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