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510(k) Data Aggregation

    K Number
    K971157
    Device Name
    MACRALP(A) ENZYME IMMUNOASSAY KIT
    Manufacturer
    STRATEGIC DIAGNOSTICS, INC.
    Date Cleared
    1998-04-15

    (383 days)

    Product Code
    JHO,DFC
    Regulation Number
    862.1475
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MACRA O LP (a) ENZYME The IN VITRO I mmuro solizant Assay (ELISA) kit is Fri CIAGNOSTIC the guartititive DEVICE FOR MIEASUILEMEN ASSESSment Ob SErum or plasma FOR CONCON ary heart 017EASE Risk OF F OLL )之:: SPECIFIC DORULLATIONS ALONG WITH Official FACTORS.

    Device Description

    IN VITRO I mmuro solizant Assay (ELISA) kit

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the MACRA Lp(a) Enzyme Immunoassay Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory clearance and not a detailed technical or clinical study report.

    Therefore, I cannot provide the requested information based on the given text.

    To answer your questions, I would need a different type of document, such as:

    • A summary of safety and effectiveness (SSE) from the 510(k) submission.
    • A clinical study report.
    • The device's instructions for use (IFU) or technical specifications.
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