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510(k) Data Aggregation

    K Number
    K981444
    Device Name
    BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
    Manufacturer
    PRINCETON BIOMEDITECH CORP.
    Date Cleared
    1998-07-22

    (91 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

    Immunoassay for in vitro diagnostic use in hospital, clinical laboratories and physicians' offices for the detection of Human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy.

    Device Description

    Not Found

    AI/ML Overview

    The document provided is a 510(k) clearance letter from the FDA for a pregnancy test strip. It does not contain the detailed information necessary to complete a table of acceptance criteria and a study description as requested. The letter primarily states that the device is substantially equivalent to previously marketed devices and outlines regulatory responsibilities.

    Therefore, I cannot provide the requested information based on the given input. The document does not include:

    1. A table of acceptance criteria or reported device performance.
    2. Sample size, data provenance, number or qualifications of experts, or adjudication methods for any test set.
    3. Information on multi-reader multi-case studies or standalone algorithm performance.
    4. Details on the type of ground truth used or how ground truth was established for training sets.
    5. Sample size for any training set.
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