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510(k) Data Aggregation

    K Number
    K030705
    Device Name
    CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL
    Manufacturer
    CLINIQA CORPORATION
    Date Cleared
    2003-03-26

    (20 days)

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

    CLINIQA Liquid QC™ Tumor Marker Control for serum protein and tumor marker analysis is intended for use as an assayed quality control material for serum protein and tumor marker analysis

    Device Description

    CLINIQA Liquid QC™ Tumor Marker Control Level 1 CLINIQA Liquid QC™ Tumor Marker Control Level 2 CLINIQA Liquid QC™ Tumor Marker Control Level 3 CLINIQA Liquid QCTM Tumor Marker Control, Tri-Level

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA to Cliniqa Corporation regarding their CLINIQA Liquid QC™ Tumor Marker Control. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

    The document does not contain any information about acceptance criteria, device performance, sample sizes used, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.

    The content is primarily a regulatory approval letter. Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.

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