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510(k) Data Aggregation

    K Number
    K991067
    Device Name
    MODIFICATION OF: DAVIDSTRIP HCG
    Manufacturer
    SIMEX MEDICAL, INC.
    Date Cleared
    1999-04-27

    (28 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DavidStrip hCG is a qualitative, two site sandwich immunoassay test kit for the rapid determination of hCG concentration in urine for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for professional use only.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "DavidStrip hCG." It does not contain a study that describes acceptance criteria and device performance. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. This type of information is usually found in the 510(k) submission itself, which is not provided in this document.

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