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510(k) Data Aggregation

    K Number
    K990741
    Device Name
    SAS ONE-STEP PREGNANCY
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1999-05-10

    (63 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K964995
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SASTM One-Step Pregnancy is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. This test is for professional use only.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a pregnancy test, not a study report. It does not contain the specific information required to answer your questions about acceptance criteria and a study proving device performance. The letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not detail the performance studies themselves.

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

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