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510(k) Data Aggregation

    K Number
    K984102
    Device Name
    ACL/APS FACS KIT
    Manufacturer
    LOUISVILLE APL DIAGNOSTICS, INC.
    Date Cleared
    1999-03-18

    (121 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The aCL/aPS®FACS Kit is and assay for the semi-quantitative determination of antiphospholipid (anticardiolipin-aCL and antiphosphatidy/serine-aPS) antibodies to be used in the aid of the diagnosis of the Antiphospholipid Syndrome (APS). APS is defined as a disorder of recurrent thrombosis, pregnancy loss and/or thrombocytopenia with persistent positive antiphospholipid tests.

    Device Description

    ACL/aPS FACS Kit

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for the ACL/APS FACS Kit. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It outlines regulatory requirements and provides contact information for various FDA offices.

    To provide the requested information, I would need to analyze a different document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) submission itself, if available.

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