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    K Number
    K113506
    Device Name
    IND ONE STEP OCCULT BLOOD (FOB) TEST
    Manufacturer
    IND DIAGNOSTICS INC.
    Date Cleared
    2012-12-19

    (387 days)

    Product Code
    KHE
    Regulation Number
    864.6550
    Type
    Special
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    IND DIAGNOSTICS INC.

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

    The One Step Fecal Occult Blood (FOB) Test is a simple, direct binding immunoassay for the rapid and the qualitative detection of fecal occult blood by laboratories or physician's offices. It is useful to determine gastrointestinal bleeding found in gastrointestinal disorders. For professional in vitro diagnostic use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria, device performance, or any studies related to the IND One Step Fecal Occult Blood Test. The document is an FDA 510(k) clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the specific performance studies, acceptance criteria, or their results.

    Therefore, I cannot provide the requested information based on the input text.

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    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?
    Applicant Name (Manufacturer) :

    IND DIAGNOSTICS INC.

    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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