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510(k) Data Aggregation

    K Number
    K013420
    Device Name
    CHEMWELL, ALSO KNOWN AS PROJECT 2900
    Manufacturer
    AWARENESS TECHNOLOGY, INC.
    Date Cleared
    2002-07-19

    (277 days)

    Product Code
    JLW,CDP,KLT
    Regulation Number
    862.1690
    Type
    Abbreviated
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CHEMWELL, ALSO KNOWN AS PROJECT 2900

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

    ChemWell will be used by laboratory technologists to obtain blood chemistry information from patient serum samples. The following quantitative UBI ELISA kits are included in this 510(k): thyroid stimulating hormone (TSH), total triiodothyronine (T3) and total thyroxine (T4). The measurement of these hormones is used for the diagnosis of thyroid disorders.

    Device Description

    ChemWell, also known as project 2900, used for United Biotech. Inc. (UBI) kits.

    AI/ML Overview

    This is an FDA Premarket Notification (510(k)) decision letter. It states that the device, 'ChemWell, also know as project 2900, used for United Biotech, Inc. (UBI) kits', is substantially equivalent to a predicate device. This letter does not include acceptance criteria or a study proving the device meets acceptance criteria. It mentions the indications for use, but no performance data. Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details.

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