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510(k) Data Aggregation

    K Number
    K991193
    Device Name
    SAS HCG-CHECK
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1999-05-04

    (26 days)

    Product Code
    LCX
    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

    SASTM hCG-Check is a rapid visual test for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. This test is for over-the-counter home use.

    Device Description

    SAS™ hCG-Check is a rapid visual test for the qualitative detection of human chorionic gonadotropin (hCG) in urine.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the SAS™ hCG-Check device, which is a rapid visual test for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This document does not contain any information regarding specific acceptance criteria, study details, or performance data as requested in the prompt.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria using only the provided text. The document primarily focuses on regulatory approval, substantial equivalence, and general administrative information.

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