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510(k) Data Aggregation

    K Number
    K053236
    Device Name
    DAVID PREGNANCY TEST (MIDSTREAM)
    Manufacturer
    RUNBIO BIOTECH CO., LTD.
    Date Cleared
    2006-07-18

    (242 days)

    Product Code
    LCX
    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

    DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY. IT IS FOR THE OVER-THE-COUNTER-USE

    Device Description

    DAVID PREGNANCY TEST IS A SELF-TESTING IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETERMINATION OF HUMAN CHORIONIC GONADOTROPIN (HCG) IN THE URINE TO AID IN EARLY DETECTION OF PREGNANCY. IT IS FOR THE OVER-THE-COUNTER-USE

    AI/ML Overview

    The provided text describes a 510(k) summary for the "DAVID PREGNANCY TEST (STRIP AND MIDSTREAM)". However, it does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment.

    The document primarily focuses on:

    • Contact details for the submitter and manufacturer.
    • Device name, classification, and intended use.
    • FDA's letter confirming substantial equivalence to a predicate device.
    • Indications for Use.

    Therefore, I cannot fulfill the request to describe acceptance criteria, device performance, or study details, as this information is not present in the provided text.

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