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510(k) Data Aggregation

    K Number
    K011689
    Device Name
    HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
    Manufacturer
    CATCH, INC.
    Date Cleared
    2001-07-25

    (55 days)

    Product Code
    LPS
    Regulation Number
    862.1377
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    K062808
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serve or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.

    Device Description

    Homogeneous Enzymic Homocysteine Reagent

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a Homogeneous Enzymic Homocysteine Reagent. It confirms that the device is substantially equivalent to previously marketed devices. However, this document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

    The letter is a regulatory approval document and focuses on the administrative aspects of device clearance, such as classification, regulation, and marketing permission, rather than the detailed technical study results that would typically include acceptance criteria and performance data.

    Therefore, I cannot provide the requested table and study details based solely on the input document.

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