LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981892
    Device Name
    QUICK & SURE ONESTEP HOME PREGNANCY TEST
    Manufacturer
    ABACUS DIAGNOSTICS
    Date Cleared
    1998-08-18

    (81 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

    Quick & Sure Onestep Home Pregnancy Test is the Abacus Diagnostics name for an "over-the-counter" (OTC) solid phase immunoassay in vitro diagnostic test kit for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an indicator of Pregnancy.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a home pregnancy test, confirming its substantial equivalence to previously marketed devices. It does not include specific study design, performance metrics, or ground truth establishment details.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1