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510(k) Data Aggregation

    K Number
    K980205
    Device Name
    SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST
    Manufacturer
    SAN DIEGO BIOTECH
    Date Cleared
    1998-02-12

    (23 days)

    Product Code
    JHI
    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

    The San Diego Biotech HCG Pregnancy Dipstick Test is intended for the qualitative determination of human chorionic gonadotropin (hCG), in urine for early detection of pregnancy. This test is intended for professional and Laboratory use only.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the San Diego Biotech HCG Pregnancy Dipstick Test and does not contain detailed information about the acceptance criteria and study proving device performance. The letter confirms substantial equivalence to a predicate device but does not include the specifics of the performance study that would show how the device meets acceptance criteria.

    Therefore, I cannot provide the requested information from the given text.

    To answer your request, I would need a different document, such as the 510(k) summary or the actual performance study report submitted by San Diego Biotech.

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