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510(k) Data Aggregation

    K Number
    K974060
    Device Name
    MINISTRIP/ SERUM AND URINE COMBO HCG TEST
    Manufacturer
    INTERNATIONAL NEWTECH DEVELOPMENT, INC.
    Date Cleared
    1998-04-09

    (164 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MINISTRIP/ SERUM AND URINE COMBO HCG TEST

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

    MiniStrip/ Serum and Urine Combo HCG test is a qualitative, two sites sandwich immunoassay test kit for rapid determination of hCG concentration in both serum and urine for early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for clinical lab used only.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Ministrip / Serum and Urine Combo HCG Test". This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

    However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter focuses on regulatory approval based on substantial equivalence, not on a detailed presentation of performance data or acceptance criteria.

    Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval letter, not a scientific study report.

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