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510(k) Data Aggregation

    K Number
    K980316
    Device Name
    ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    1998-02-12

    (16 days)

    Product Code
    CJE
    Regulation Number
    862.1050
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the quantitative determination of Alkaline Phosphatase in serum. For IN VITRO diagnostic use. Elevated alkaline phosphatase activity in serum is of interest in the diagnosis of several disease conditions including hepatobiliary disease and bone disease associated with increased osteoblastic activity. Alkaline phosphatase activity in serum may be elevated due to obstructive jaundice, occlusion of the common bile or hepatic duct, and cirrhosis.

    Device Description

    Alkaline Phosphatase-SL Assay

    AI/ML Overview

    The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the "Alkaline Phosphatase-SL Assay" device. These documents pertain to an in vitro diagnostic assay, not an AI/ML-powered device.

    Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) regarding an AI/ML device is not applicable to this submission. The documents describe a laboratory assay for measuring alkaline phosphatase levels, which is a chemical test, not a software-based diagnostic tool.

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