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510(k) Data Aggregation

    K Number
    K021384
    Device Name
    LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
    Manufacturer
    BIO-RAD
    Date Cleared
    2002-05-29

    (27 days)

    Product Code
    DIF,REG
    Regulation Number
    862.3280
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K981590
    Why did this record match?
    Device Name :

    LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444

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

    A quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures.

    Device Description

    Liquichek™ Urine Toxicology Control Levels C1, C2, C3 and C4 is prepared from human urine with added constituents of animal origin, drugs, drug metabolites, preservatives, and stabilizers. The control is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Liquichek™ Urine Toxicology Control Levels C1, C2, C3, and C4:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission form for the Liquichek™ Urine Toxicology Control Levels C1, C2, C3, and C4 is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo acceptance criteria and proving performance against them in the same way a PMA submission might.

    Therefore, the "acceptance criteria" for this device are largely implicit in its comparison to the predicate device and the demonstration of stability. The "reported device performance" primarily relates to its stability under various conditions.

    Acceptance Criteria (Implicit)Reported Device Performance
    Intended Use Equivalence: Monitor performance of laboratory urine toxicology confirmatory procedures (same as predicate).The device's intended use is identical to the predicate device.
    Form Equivalence: Liquid form (same as predicate).The device is provided in liquid form.
    Matrix Equivalence: Human urine matrix (same as predicate).The device is prepared from human urine.
    Open Vial Stability: Stable for 30 days when stored tightly capped at 2-8°C.Open vial stability: 30 days when stored at 2-8°C.
    Shelf Life Stability: Stable for the declared shelf life when stored at 2-8°C. (Initial claim: 24 months).Shelf life: 24 months when stored at 2-8°C. (Real-time studies ongoing).
    Performance in Toxicology Confirmatory Procedures: Function effectively as a quality control for the listed analytes (implied by intended use and comparison to predicate).The device includes the same analytes as the predicate, plus additional claims for Creatinine, pH, and Specific Gravity.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not explicitly state the sample size used for the stability studies or provide details on the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Stability studies have been performed" and "All supporting data is retained on file at Bio-Rad Laboratories."

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    This information is not provided in the document. For a quality control material like this, "ground truth" for stability would typically be established through analytical testing against known reference materials or validated methods, rather than expert consensus on diagnostic interpretations.

    4. Adjudication Method for the Test Set

    This information is not provided. Adjudication methods (like 2+1 or 3+1) are typically used for diagnostic studies involving human interpretation or subjective assessments, which is not directly applicable to the stability testing of a quality control material.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No MRMC comparative effectiveness study was mentioned or performed. This type of study is relevant for evaluating the impact of a device on human reader performance, which doesn't apply to a quality control material.

    6. Standalone Performance Study

    The focus of the submission is demonstrating substantial equivalence to a predicate device and proving the stability of the new device. The "performance" studies described are the stability studies. These are inherently standalone tests of the device's characteristics (e.g., concentration of analytes over time).

    7. Type of Ground Truth Used

    For the stability studies, the "ground truth" would be the analytical measurement of the analytes within the quality control material over time, compared to established reference values or specifications for stability. The document does not explicitly detail the methods used to establish these reference values, but it's implied to be internal analytical validation.

    8. Sample Size for the Training Set

    This product is a quality control material, not an algorithm or diagnostic model that requires a "training set" in the machine learning sense. Therefore, there is no training set mentioned or applicable for this device.

    9. How the Ground Truth for the Training Set Was Established

    As there is no training set, this question is not applicable.

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