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510(k) Data Aggregation

    K Number
    K020845
    Device Name
    EMIT 2000 VANCOMYCIN CALIBRATORS
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2002-05-08

    (54 days)

    Product Code
    DLJ
    Regulation Number
    862.3200
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K881040
    Why did this record match?
    Device Name :

    EMIT 2000 VANCOMYCIN CALIBRATORS

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

    The Emit® 2000 Vancomycin Calibrators are intended for use with the Emit® 2000 Vancomycin Assay as a reference for use in determining vancomycin levels in human serum or plasma.

    Device Description

    Emit® 2000 Vancomycin Calibrators are liquid, six-level calibrators prepared from vancomycin, buffer and preservatives. The calibrators are intended for use with the Emit® 2000 Vancomycin Assay as a reference for use in determining vancomycin levels in human serum or plasma.

    AI/ML Overview

    The provided text describes information about a medical device, the "Emit® 2000 Vancomycin Calibrators," and its 510(k) submission. However, it does not contain the detailed performance study information typically associated with acceptance criteria and a study proving a device meets those criteria for image-based diagnostic AI/ML products.

    This document describes a calibrator device, which is used to calibrate an assay, rather than a diagnostic AI/ML system that directly analyzes data for diagnosis. The performance characteristics described are related to the stability and manufacturing consistency of the calibrator itself, not the diagnostic performance of an AI system.

    Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or not provided in the context of this device.

    Here's an attempt to extract relevant information and note what is unavailable:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryDescription / Reported Performance
    Intended UseThe Emit® 2000 Vancomycin Calibrators are intended for use with the Emit® 2000 Vancomycin Assay as a reference for use in determining vancomycin levels in human serum or plasma.
    Substantial EquivalenceSubstantially equivalent in intended use to the Emit® Vancomycin Calibrators (K881040). The modified Emit® 2000 Vancomycin Calibrators contain the same vancomycin concentrations as the currently marketed device. Both devices are intended for use in the calibration of human serum or plasma in conjunction with a Vancomycin Reagent.
    Shelf Life StabilityAcceptance Criteria (Implied): No significant change in recovery over time.
    Reported Performance: Stability studies support no significant change in recovery for at least 13 months. The assignment of shelf life will be based on real-time data.
    Preparation / Lot ConsistencyAcceptance Criteria (Implied): Calibrator levels are adjusted as needed to match Emit® 2000 responses of a Master Lot.
    Reported Performance: Each new calibrator lot is tested in bulk and final container stages with 20 replicates at each calibrator level. These values are compared to a Master Lot.

    Study Details

    1. Sample size used for the test set and the data provenance:

      • For Shelf Life Stability: "at least 3 lots of calibrators" were used, stored at 9°C with comparison to calibrator sets stored at -20°C. Data provenance is implied to be internal testing by Dade Behring Inc. (retrospective data from real-time monitoring).
      • For Preparation / Lot Consistency: "20 replicates at each calibrator level" were tested for each new calibrator lot. Data provenance is implied to be internal manufacturing quality control by Dade Behring Inc.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a calibrator, not a diagnostic device requiring expert interpretation of medical data. The "ground truth" for calibrators relates to their accurate concentration and stability.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

    4. 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: Not applicable. This is not an AI/ML-based diagnostic device.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this calibrator device is based on "standard gravimetric procedures" to prepare the calibrators with known vancomycin concentrations and then comparing the lot's response to a "Master Lot" for consistency.

    7. The sample size for the training set: Not applicable in the context of an AI/ML training set. The descriptions relate to manufacturing and stability testing procedures.

    8. How the ground truth for the training set was established: Not applicable.

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