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510(k) Data Aggregation

    K Number
    K041728
    Device Name
    HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
    Manufacturer
    IMMUNOSTICS, INC.
    Date Cleared
    2004-08-11

    (47 days)

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

    HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE

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

    The Immuno / hCG Detector™ - Urine is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

    The Immuno / hCG Detector Stix is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

    The Immuno / hCG Detector Combi™ is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Immuno/hCG Detector™". It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. It primarily states that the device is substantially equivalent to legally marketed predicate devices for the detection of Human Chorionic Gonadotropin (hCG) in urine for early pregnancy detection, and that it is intended for professional and laboratory use only.

    Therefore, I cannot extract the requested information from the given input.

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