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510(k) Data Aggregation

    K Number
    K013698
    Device Name
    AST (SGOT)
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2001-12-21

    (44 days)

    Product Code
    CIT
    Regulation Number
    862.1100
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended for the In Vitro, quantitative determination of aspartate amino transferase (AST) in human serum on automated chemistry analyzers.

    Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for an in vitro diagnostic device, the AST (SGOT) REAGENT. It is a regulatory approval, not a scientific study report. Therefore, the provided text does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement in a performance study.

    The document only states the "Indications for Use":

    Device Name: AST (SGOT) REAGENT

    Indications for Use: Intended for the In Vitro, quantitative determination of aspartate amino transferase (AST) in human serum on automated chemistry analyzers. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

    To answer your request, a separate study report or a more detailed filing from JAS Diagnostics, Inc. to the FDA would be needed. This letter primarily confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

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