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510(k) Data Aggregation

    K Number
    K020438
    Device Name
    SAS VALUE HCG
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    2002-03-08

    (25 days)

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

    SAS VALUE HCG

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

    SASTM Value hCG is a visual test for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine.to aid in the early detection of pregnancy. The test is for professional use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

    The document is an FDA 510(k) clearance letter for the "SASTM Value hCG" device, stating its substantial equivalence to a legally marketed predicate device. It defines the device's indications for use (qualitative detection of human chorionic gonadotropin in serum or urine to aid in early pregnancy detection for professional use). However, it does not include performance data or study details.

    Therefore, I cannot fulfill your request for the specific information you've asked for.

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