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510(k) Data Aggregation

    K Number
    K020282
    Device Name
    JAS AMYLASE LIQUID REAGENT
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2002-02-28

    (31 days)

    Product Code
    JFJ
    Regulation Number
    862.1070
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    JAS AMYLASE LIQUID REAGENT

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

    Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers.

    Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the "Amylase Reagent" device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

    The letter primarily:

    • Confirms that the device is substantially equivalent to a legally marketed predicate device.
    • Outlines the regulatory requirements for the device.
    • Grants permission to market the device.
    • Provides contact information for regulatory inquiries.

    The "Indications for Use" section (Page 2 of the original document) states: "Intended for the In Vitro, quantitative determination of amylase in human serum on automated chemistry analyzers. Amylase measurements are used in the diagnosis and treatment of pancreatitis (inflammation of the pancreas)."

    However, no specific performance metrics like sensitivity, specificity, accuracy, precision, or recovery are mentioned, nor is there any description of a study conducted to demonstrate these. Therefore, I cannot extract the requested information regarding acceptance criteria or a study from this document.

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