LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022401
    Device Name
    PTS PANELS MULTI-CHEMISTRY CONTROLS
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Date Cleared
    2002-08-21

    (29 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K012117,K012119
    Why did this record match?
    Device Name :

    PTS PANELS MULTI-CHEMISTRY CONTROLS

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

    The PTS PANELS Multi-Chemistry Controls are intended for use to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home.

    The PTS PANELS Multi-Chemistry Controls are intended for use on the BioScanner 2000 and CardioChek brand instruments to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home.

    Device Description

    The PTS PANELS Multi-Chemistry Controls consist of multiple levels of aqueous controls containing cholesterol, triglycerides, ketone (Bhydroxybutyrate) and glucose.

    AI/ML Overview

    The provided text describes a 510(k) submission for "PTS PANELS Multi-Chemistry Controls" and the FDA's clearance. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

    The document details:

    • Applicant Information: Polymer Technology Systems, Inc.
    • Device Description: Aqueous controls containing cholesterol, triglycerides, ketone (B-hydroxybutyrate), and glucose.
    • Intended Use: To estimate precision and detect systematic analytical deviations from reagent or instrument variation, for use by healthcare professionals and consumers.
    • Predicate Devices: Maine Standards Validate Chem 1 and Chem 3.
    • Similarities and Differences between the new device and the predicate devices, primarily regarding the analytes included and the base matrix (aqueous vs. protein-based for one predicate).
    • FDA Clearance Letter: Indicating substantial equivalence to marketed predicate devices.

    Therefore, I cannot provide the requested table or answer the questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1