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510(k) Data Aggregation

    K Number
    K023928
    Device Name
    MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
    Manufacturer
    MEDICAL ANALYSIS SYSTEMS, INC.
    Date Cleared
    2002-12-11

    (16 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL

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

    MAS® UA Control is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis.

    DADE® UA Control is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. UA Control may be used in conjunction with commercially available standardized systems for urine microscopic analysis.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a 510(k) clearance letter from the FDA for two urinalysis control devices: MAS® UA Control and DADE® UA Control. This document is a regulatory approval and does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment that you've requested.

    The letter simply states that the devices are substantially equivalent to legally marketed predicate devices and outlines their intended use as quality control materials for urinalysis testing.

    Therefore, I cannot extract the specific information you've asked for from this document. To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a detailed study report for these devices.

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