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    K Number
    K021151
    Device Name
    AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
    Manufacturer
    BAYER DIAGNOSTICS CORP.
    Date Cleared
    2002-07-13

    (94 days)

    Product Code
    JIF
    Regulation Number
    862.1065
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K760332
    Why did this record match?
    Reference Devices :

    Sigma, K760332

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

    The Bayer ADVIA IMS Ammonia (NH3) assay is an in vitro diagnostic device intended to measure Ammonia in human plasma (K3EDTA). Measurements of ammonia are used as an aid in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye's syndrome.

    The Bayer ADVIA IMS Ammonia method is an in vitro diagnostic device intended to measure ammonia levels in human plasma. Such measurements are used in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye's syndrome.

    Device Description

    Not Found

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Ammonia method for ADVIA® IMS™, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implied by the comparison to the predicate device (Sigma Ammonia) and the determination that the ADVIA IMS Ammonia Assay's performance is "equivalent" and "within proposed manufacturing specifications." The provided data serves as the basis for demonstrating this equivalency.

    CharacteristicAcceptance Criteria (Implied by Predicate Performance)Reported Device Performance (ADVIA IMS)
    Imprecision (Total CV%)Comparable to Sigma Ammonia's CV% at similar levels (e.g., 4.2% at 52.9 umol/L, 1.7% at 323 umol/L, 1.8% at 490 umol/L)15.8% at 21.4 umol/L, 3.5% at 112 umol/L, 4.3% at 234 umol/L
    Correlation (to predicate)High correlation (R ~0.998), low Syx (9.7 umol/L), and regression equation (Y=0.93X+14.8) indicating close agreement.Y=0.93X+14.8, Syx = 9.7 umol/L, R = 0.998
    Interfering SubstancesAcceptable effect on ammonia concentration (e.g., small % change for specified interfering substances at given concentrations).Bilirubin (unconjugated) 18.8 mg/dL: -8.0%
    Bilirubin (conjugated) 25 mg/dL: +3.0%
    Hemoglobin 500 mg/dL: +11.0%
    Lipids (Triglycerides) 500 mg/dL: -12.0%
    Analytical RangeComparable to clinically relevant range.5 - 500 umol/L

    Study Details

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

      • Sample Size: 51 specimens for the correlation study.
      • Data Provenance: Not explicitly stated whether retrospective or prospective, or country of origin. The specimens are "human plasma (K3EDTA)".

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

      • Not applicable/Not provided. This device is a quantitative assay, and the "ground truth" for the test set is established by the comparative system (predicate device), not expert consensus.

    3. Adjudication method for the test set:

      • Not applicable. As a quantitative assay compared to a predicate device, adjudication methods by experts are not relevant here.

    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:

      • No, an MRMC study was not done. This is a submission for an in vitro diagnostic device, not an AI-assisted diagnostic tool involving human readers.

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

      • Yes, this is a standalone device performance study. The "algorithm" here refers to the chemical assay method performed by the ADVIA IMS system. The performance metrics (imprecision, correlation, interference, analytical range) reflect the device's capability without human interpretation or intervention in the results beyond standard laboratory operation.

    6. The type of ground truth used:

      • Comparative Reference Method: The predicate device, Sigma Ammonia, run on a Fara II system, served as the comparative reference for establishing the performance characteristics, particularly for correlation. The performance is deemed "equivalent" to this predicate.

    7. The sample size for the training set:

      • Not applicable/Not provided. This is a conventional chemical assay, not a machine learning or AI-based device that would typically have a separate "training set" in the computational sense. The development of the assay would involve various experimental and optimization phases, but these are not referred to as a "training set" in this context.

    8. How the ground truth for the training set was established:

      • Not applicable. See point 7. The development of the assay would rely on established biochemical principles and analytical chemistry methodologies.
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