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510(k) Data Aggregation

    K Number
    K040273
    Device Name
    LYPHOCHEK ASSAYED CHEMISTRY CONTROL
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Date Cleared
    2004-03-04

    (28 days)

    Product Code
    JJY,CFR
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K874280
    Predicate For
    K111996
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

    Device Description

    Lyphochek Assayed Chemistry Control is prepared from human serum with added constituents of purified biochemicals (tissue extracts of human and animal origin), chemicals, therapeutic drugs, preservatives and stabilizers. The control is provided in lyophilized form.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Lyphochek Assayed Chemistry Control device:

    Important Note: The provided document is a 510(k) summary for a diagnostic quality control material. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study demonstrating diagnostic performance against a ground truth for individual disease detection. The "device performance" in this context refers to the stability and claims for the control material itself.

    Acceptance Criteria and Study for Lyphochek Assayed Chemistry Control

    The Lyphochek Assayed Chemistry Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures. The "acceptance criteria" and "device performance" are related to the stability of the control material over various conditions (open vial, after reconstitution and freezing, and shelf life).

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    Open Vial StabilityAll analytes stable for 7 days at 2 to 8°CAll analytes are stable for 7 days at 2 to 8°C.
    Acid Phosphatase stable for 3 days at 2 to 8°C.Acid Phosphatase is stable for 3 days at 2 to 8°C.
    Prostatic Acid Phosphatase stable for 3 days at 2 to 8°C.Prostatic Acid Phosphatase is stable for 3 days at 2 to 8°C.
    Reconstituted & Frozen StabilityAll analytes stable for 30 days when stored at -10 to -20°C.All analytes are stable for 30 days when stored at -10 to -20°C.
    Tobramycin stable for 20 days when stored at -10 to -20°C.Tobramycin is stable for 20 days when stored at -10 to -20°C.
    Shelf LifeSufficient stability for market distribution.3 Years + 4 Months at 2 to 8°C. Real-time studies are ongoing to support this claim.

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

    The document does not specify a "test set" in the traditional sense of patient samples for a diagnostic device. It refers to stability studies of the control material itself. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) for patient data is not applicable here. The data provenance relates to the internal studies conducted by Bio-Rad Laboratories for the stability of their product.

    3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

    This information is not applicable to this type of device. The "ground truth" for a quality control material is its stability and the accuracy of its assigned values, determined through internal manufacturing and quality control processes rather than expert clinical review.

    4. Adjudication Method for the Test Set

    This is not applicable. There is no "test set" of patient data requiring adjudication by experts.

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

    This is not applicable. The device is a quality control material, not a diagnostic tool requiring human interpretation or a comparative effectiveness study with human readers.

    6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

    This is not applicable. The device is not an algorithm. Its performance is evaluated by its physical and chemical stability characteristics under various conditions.

    7. Type of Ground Truth Used

    The "ground truth" for a quality control material like this is established through internal analytical testing and manufacturing specifications. This involves:

    • Analytical measurements: Assaying the batch of control material using reference methods to determine the expected values for each analyte.
    • Stability testing: Performing longitudinal studies to assess the consistency of these values over time and under different storage conditions (temperature, open/closed vial, frozen/reconstituted).
    • Compliance with manufacturing specifications: Ensuring that the control material meets predefined limits for deviation, homogeneity, and integrity.

    8. Sample Size for the Training Set

    This is not applicable. The concept of a "training set" typically applies to AI/ML algorithms. For a quality control material, there isn't a training set in this context. The manufacturing process and formulation development could be seen as an ongoing "training" in a very broad sense, but not for an algorithm.

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

    This is not applicable for the reasons mentioned above. For this device, "ground truth" is established by rigorous analytical chemistry and stability testing within Bio-Rad Laboratories' quality management system.

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