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510(k) Data Aggregation

    K Number
    K081908
    Device Name
    CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2009-01-16

    (197 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 :

    CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2

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

    CLINIQA® Liquid QC™ DipScopics Urinalysis Control is intended for use as an assayed quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest", and Ictotest This control is also intended to evaluate microscopic examination test procedures

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter from the FDA for CLINIQA Liquid QC Urinalysis Controls, Levels 1 and 2. It confirms that the device has been found substantially equivalent to a predicate device but does not contain any details about acceptance criteria, study design, reported device performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

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