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    K Number
    K955568
    Device Name
    INNOFLUOR QUINIDINE ASSAY SYSTEM
    Manufacturer
    OXIS INTL., INC.
    Date Cleared
    1996-04-04

    (120 days)

    Product Code
    LBZ
    Regulation Number
    862.3320
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    INNOFLUOR QUINIDINE ASSAY SYSTEM

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

    Substantial equivalence has been demonstrated between the INNOFLUOR™ Quinidine Assay System (Modified) the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.

    The technological characteristics, performance and intended use of the INNOFLUOR™ Quinidine Assay System (Modified) are substantially equivalent to the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.

    Device Description

    Not Found

    AI/ML Overview

    Here's a breakdown of the provided information concerning the INNOFLUOR™ Quinidine Assay System (Modified), structured according to your request.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Substantial Equivalence to Existing Devices:Demonstrated: The INNOFLUOR™ Quinidine Assay System (Modified) is deemed substantially equivalent to the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay in terms of technological characteristics, performance, and intended use.
    Linear Regression - Slope:0.958
    Linear Regression - Intercept:-0.077
    Correlation Coefficient (r):0.986
    Assumed Implied Acceptance Range for Slope: (Not explicitly stated, but typically close to 1)0.958 (within an acceptable range around 1, though not specified here)
    Assumed Implied Acceptance Range for Intercept: (Not explicitly stated, but typically close to 0)-0.077 (within an acceptable range around 0, though not specified here)
    Assumed Implied Acceptance Range for Correlation Coefficient (r): (Not explicitly stated, but typically high, close to 1)0.986 (demonstrates strong correlation)

    Note: The document explicitly states "Substantial equivalence has been demonstrated." While specific numerical acceptance thresholds for slope, intercept, and correlation coefficient are not explicitly provided in the input, the reported values are presented as evidence supporting this claim of substantial equivalence. For a medical device, these metrics being close to 1 (for slope and correlation) and 0 (for intercept) are generally considered indicative of good agreement between methods.

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

    • Sample Size: 49 serum patient samples.
    • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "patient samples."

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

    This section is not applicable to this type of device and study. The "ground truth" for this performance study is established by a reference assay (the Abbott Quinidine Assay), not by human expert interpretation of images or clinical findings.

    4. Adjudication Method for the Test Set

    This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used when human interpretation is involved in establishing a ground truth or resolving discrepancies between reviewers. In this case, the comparison is between two analytical assays.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases, often with and without AI assistance, to assess the impact of AI on reader performance. The provided study focuses on comparing the output of an automated assay system directly against a reference assay.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    Yes, a standalone performance study was done. The INNOFLUOR™ Quinidine Assay System (Modified) is an automated assay system. Its performance was evaluated directly against a reference assay (Abbott Quinidine Assay) without human intervention in the analysis process beyond initiating the test and reading the results.

    7. The Type of Ground Truth Used

    The "ground truth" in this study is established by the Abbott Quinidine Assay. This is a reference standard or comparator method rather than one of the typical ground truth categories like "expert consensus" or "pathology" for diagnostic imaging. The performance of the modified INNOFLUOR™ system is being evaluated relative to this established, existing assay.

    8. The Sample Size for the Training Set

    The document does not provide any information about a training set size. This suggests that the INNOFLUOR™ Quinidine Assay System (Modified) is likely a re-formulation or modification of an existing assay, and its performance is being compared to established methods rather than being an AI algorithm that requires a distinct training phase in the typical sense. If there was any "training" involved, it would be in the initial development and calibration of the assay, but the document does not detail this.

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

    Since no training set information is provided, how its "ground truth" was established is also not applicable/not documented in the provided summary.

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