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    K Number
    K121759
    Device Name
    CONE-TROL LIQUID CHEMISTRY CONTROLS
    Manufacturer
    CONE BIOPRODUCTS
    Date Cleared
    2012-07-24

    (39 days)

    Product Code
    JJY,CLA
    Regulation Number
    862.1660
    Type
    Abbreviated
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k011867
    Why did this record match?
    Device Name :

    CONE-TROL LIQUID CHEMISTRY CONTROLS

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

    CONE-TROL Liquid Chemistry Control is a human liquid control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

    Device Description

    CONE-TROL Liquid Chemistry Control is prepared from human serum to which purified biochemical material (human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added. The control is provided in liquid form for user convenience.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria for performance metrics. However, we can infer the implicit "acceptance criteria" and how the device's performance aligns with them based on the stability testing described. The primary "performance" being evaluated here is the stability of the control material over time under various storage conditions.

    Acceptance Criteria (Inferred)Reported Device Performance (CONE-TROL Liquid Chemistry Control)
    Closed Vial Stability (2-8°C): Control material remains stable for at least 30 days at 2-8°C (matching predicate).Acceptable stability through 33 days at 2-8°C (real-time testing).
    Open Vial Stability (2-8°C): Control material remains stable for at least 14 days at 2-8°C after opening (matching predicate).Acceptable stability through 15 days at 2-8°C after opening and simulating handling (real-time testing).
    **Shelf Life (Frozen
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