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    K Number
    K962758
    Device Name
    DSL 9100 IGF-II IRMA
    Manufacturer
    DIAGNOSTIC SYSTEMS LABORATORIES, INC.
    Date Cleared
    1996-08-30

    (45 days)

    Product Code
    CFL
    Regulation Number
    862.1370
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DSL 9100 IGF-II IRMA

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

    The DSL IGF-II IRMA assay is intended for the quantitative determination of IGF-II in human serum or plasma. The measurement of IGF-II is used For In Vitro Diagnostic Use in the evaluation of growth status.

    Device Description

    The DSL 9100 IGF-II IRMA kit was developed for the quantitative measurement of IGF-II in human serum or plasma. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody, goat anti-IGF-II, is immobilized to the inside wall of the test tube, the other antibody, mouse monoclonal anti-IGF-II is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed be decanting and washing the tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound IGF-II is directly proportional to the concentration of the IGF-II present in the sample.

    AI/ML Overview

    This document is a Summary of Safety and Effectiveness for the DSL 9100 IGF-II IRMA Kit. It describes an In Vitro Diagnostic (IVD) device, specifically an immunoradiometric assay (IRMA) for quantitatively measuring Insulin-like Growth Factor-II (IGF-II) in human serum or plasma.

    The provided document does not contain the information requested regarding acceptance criteria related to device performance in a clinical or diagnostic study involving patient data, nor does it describe a study that uses such data to prove the device meets acceptance criteria.

    Instead, the document focuses on:

    • The name and classification of the device.
    • The submitter information.
    • The assay principle (IRMA format, sandwich immunoassay with radiolabeled antibody).
    • The intended use (in vitro diagnostic for evaluation of growth status).
    • A statement of substantial equivalence to the DSL IGF-I IRMA.

    Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text. The document is a regulatory submission summary, not a detailed clinical performance study report.

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