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510(k) Data Aggregation

    K Number
    K110889
    Device Name
    IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
    Manufacturer
    IND DIAGNOSTICS INC.
    Date Cleared
    2011-06-20

    (82 days)

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

    IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)

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

    IND One Step hCG Urine Pregnancy Tests Device is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets them. It is an FDA 510(k) clearance letter for the "IND One Step hCG Urine Pregnancy Test (Strip)", indicating that the device has been found substantially equivalent to legally marketed predicate devices.

    The letter does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about sample sizes, data provenance, or ground truth establishment for any test sets.
    • Information regarding expert involvement, adjudication methods, or MRMC studies.
    • A description of standalone algorithm performance.
    • Sample size or ground truth methods for a training set.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided document. The document is solely an FDA clearance letter affirming substantial equivalence for marketing.

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