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510(k) Data Aggregation

    K Number
    K021498
    Device Name
    LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
    Manufacturer
    BIO-RAD
    Date Cleared
    2002-05-24

    (15 days)

    Product Code
    JJT,CFR
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K012656,K961828
    Why did this record match?
    Device Name :

    LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL

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

    Liquichek™ Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.

    Device Description

    Liquichek™ Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form for convenience.

    AI/ML Overview

    The document describes the device, Liquichek™ Cardiac Markers Control LT, as an assayed quality control serum. The "acceptance criteria" in this context refers to the stability of the analytes within the control serum under specified storage conditions, which determines its shelf life and open-vial stability. The study conducted to "prove the device meets the acceptance criteria" is a series of stability studies.

    Here's a breakdown of the requested information based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Measured Performance)Reported Device Performance
    Open Vial Stability (2-8°C, tightly capped)
    - Troponin-I, Troponin T, and Homocysteine stability10 days
    - Myoglobin, CK-MB, and Digitoxin stability20 days
    Shelf Life (Unopened, -20°C or colder)2 years
    PreservativesContains a broad-spectrum anti-microbial cocktail (
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