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    K Number
    K142181
    Device Name
    RANDOX ALDOLASE CALIBRATION SERUM
    Manufacturer
    RANDOX LABORATORIES LIMITED
    Date Cleared
    2014-09-18

    (41 days)

    Product Code
    JIT
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k053153
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    Device Name :

    RANDOX ALDOLASE CALIBRATION SERUM

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

    The Aldolase Calibration Serum is intended for in vitro diagnostic use in the calibration of Aldolase on the Randox RX Daytona and Beckman Coulter AU640 systems. This device is for prescription use only.

    Device Description

    The Aldolase Calibrator is supplied in a kit containing 3x1ml vial of lyophilized serum is reconstituted with exactly 1 ml of distilled water and is stable for 5 days when reconstituted and stored at +2°C to +8° C.

    The base matrix used for the manufacture of the Aldolase Calibration Serum is Human Serum with added chemicals.

    Human source material from which this product has been derived and has been tested at the donor level for the Human Immunodeficiency Virus (HIV1 & HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV) antibody and were found to be non-reactive based on FDA approved methods.

    However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.

    AI/ML Overview

    The provided document describes the Randox Aldolase Calibration Serum. Here's a breakdown of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test TypeAcceptance CriteriaReported Device Performance
    Open Vial StabilityPercentage deviation of reconstituted to fresh should be ≤5%.Current open vial studies support a reconstituted claim of 5 days when stored at +2°C to +8°C.
    Real Time Testing (Shelf Life)Calibrator recovery for routinely stored compared to ultra-frozen should be within +/-5% deviation and all controls should be within range.Current Real Time studies support a 2-year shelf life.
    Value Assignment (Precision)Precision measured by the CV should be less than or equal to 3%.RX Daytona: CV = 2.2%
    Beckman Coulter AU640: CV = 1.8%

    2. Sample size used for the test set and the data provenance

    • Open Vial Stability: The document states "Samples were reconstituted and stored...and tested for Aldolase." It does not specify the exact number of samples (vials) used, but it implies a sufficient number for testing the 7-day stability.
    • Real Time Testing: The document refers to "routinely stored calibrators are compared to the ultra frozen calibrators at various time points." It doesn't specify the exact sample size or number of comparisons.
    • Value Assignment: For the precision study, N=10 replicates were performed for each instrument (RX Daytona and Beckman Coulter AU640).
    • Data Provenance: The studies were conducted by Randox Laboratories, Ltd., which is based in the United Kingdom. The studies appear to be prospective as they are verifying and validating the performance characteristics of the new device.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    This section is not applicable as the device is a calibration serum, not a diagnostic imaging or AI-driven interpretative device that requires expert review for ground truth. The "ground truth" here is the assigned value of the calibrator, derived from established reference calibrators or consensus values.

    4. Adjudication method for the test set

    This section is not applicable for the reasons stated above. Adjudication is not relevant for the performance evaluation of a calibration serum.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools that assist human readers, which is not the nature of this calibration serum.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    This section is not applicable. The device is a calibration serum used in conjunction with analytical instruments (Randox RX Daytona and Beckman Coulter AU640) for calibrating aldolase assays. It is not an algorithm or AI system. Its performance is demonstrated through its ability to provide stable and precise values according to established measurement principles, not as a standalone interpretive algorithm.

    7. The type of ground truth used

    The ground truth for the Randox Aldolase Calibration Serum values is based on:

    • Nested testing against a master lot calibrator: The master lot's value assignment was derived using a Randox calibrator with established consensus values or an International Reference Preparation (IRP) where available and applicable. This implies traceability to primary or secondary reference materials.
    • For the precision study, the "ground truth" (or target value) for the Aldolase concentration is established through this hierarchical value assignment process.

    8. The sample size for the training set

    This section is not applicable. This is a calibration serum, not a machine learning model, so there is no "training set."

    9. How the ground truth for the training set was established

    This section is not applicable as there is no training set for this device.

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