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510(k) Data Aggregation

    K Number
    K083554
    Device Name
    CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2009-04-21

    (141 days)

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

    CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3

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

    CLINIQA® Liquid QC™ ImmunoAssay Controls, Levels 1, 2, & 3 are assayed, liquid, quality control products which may be used to evaluate the assaycu, liquid, quality control procuments an analytes listed in the product insert.

    Device Description

    assayed, liquid, quality control products

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the CLINIQA® Liquid QC™ Immunoassay Control. It confirms substantial equivalence to a predicate device and outlines regulatory compliance. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested information based on the provided text. The document is primarily an FDA clearance letter and lacks the technical details of a device study.

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