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510(k) Data Aggregation

    K Number
    K031048
    Device Name
    CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
    Manufacturer
    ACCESS BIO INCORPORATE
    Date Cleared
    2003-06-16

    (75 days)

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

    CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST

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

    CareStart™ hCG Combo One Step Pregnancy Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for a pregnancy test device, not an AI device. As such, the information typically requested for AI device studies (like acceptance criteria tables, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment methods) is not available in the document.

    Therefore, I cannot provide the requested information from the text you provided.

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