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510(k) Data Aggregation

    K Number
    K981933
    Device Name
    URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2
    Manufacturer
    MEDICAL ANALYSIS SYSTEMS, INC.
    Date Cleared
    1998-06-29

    (27 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    K991917
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    UrichemTRAK Liguid Assayed Control is a human urine based quality control material used in various general chemistry assays. The product is intended for use as a consistent test sample of known concentrations that is assayed along with patient urine specimens when performing urine chemistry assays. The Clinician can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.

    Device Description

    UrichemTRAK Liquid Assayed Control, Levels 1 and 2

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Urichem TRAK Liquid Assayed Control, Levels 1 and 2." This document primarily focuses on regulatory approval, intended use, and general controls.

    It does not contain the detailed information required to answer your request about acceptance criteria and the specifics of a study proving the device meets those criteria. Specifically, the document does not provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts used to establish ground truth and their qualifications.
    4. Adjudication method.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Details on standalone (algorithm only) performance.
    7. The type of ground truth used (expert consensus, pathology, etc.).
    8. The sample size for the training set.
    9. How the ground truth for the training set was established.

    The document states the device's "Statement of Indications for Use" as a quality control material for general chemistry assays, intended for evaluating analytical precision, reagent, and instrument performance. This type of device is a control material, not typically an AI-powered diagnostic or decision support system that would undergo the kind of detailed performance studies you're asking about in the context of AI.

    Therefore, I cannot fulfill your request based on the provided input.

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