LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030860
    Device Name
    ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
    Manufacturer
    MONOBIND
    Date Cleared
    2003-08-22

    (157 days)

    Product Code
    KLI
    Regulation Number
    862.1700
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300

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

    The test is intended for the quantitative determination of Thyroxine (T4) in blood specimens dried on the filter paper for screening newborns for congenital (neonatal) hypothyroidism.

    Device Description

    AccuBind™ Neo-Natal T4 Microplate EIA

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for a medical device (AccuBind™ Neo-Natal T4 Microplate EIA) and its "Indications for Use" statement. It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. This type of regulatory document confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not typically include the detailed scientific study data or performance metrics you've requested.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The requested information (points 1-9) would typically be found in a separate submission document or a scientific publication related to the device's validation.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1