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    K Number
    K970546
    Device Name
    ACS DIGITOXIN
    Manufacturer
    CHIRON DIAGNOSTICS CORP.
    Date Cleared
    1997-07-14

    (152 days)

    Product Code
    LFM
    Regulation Number
    862.3300
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACS DIGITOXIN

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

    The Chiron Diagnostics ACS:180 Digitoxin Assay is for the quantitative determination of digitoxin in serum or plasma using the Chiron ACS:180 Automated Chemiluminescence System. Monitoring of serum digitoxin concentrations is necessary to maintain therapeutic efficacy and avoid toxicity. Serum digitoxin levels combined with other therapeutic and clinical information provide the clinician with useful information to aid in adjusting patient dosage, achieving optimal therapeutic effect, and avoiding useless subtherapeutic or harmful toxic doses.

    Device Description

    The Chiron Diagnostics ACS:180 Digitoxin assay is a competitive immunoassay using direct, chemilumenescent technology. Digitoxin in the patient sample competes with digitoxin, which is covalently coupled to the paramagnetic particles in the Solid Phase for binding to the acridinium ester-labeled monoclonal anti-digitoxin antibody in the Lite Reagent. An inverse relationship exists between the amount of digitoxin in the patient sample and the amount of relative light units (RLUs) detected by the ACS:180® system.

    AI/ML Overview

    The provided document describes the Chiron Diagnostics ACS Digitoxin assay, comparing its performance to an alternate fluorescence polarization (FPIA) method.

    Here's a breakdown of the acceptance criteria and study details:

    1. Table of Acceptance Criteria and Reported Device Performance

    FeatureAcceptance Criteria (Implied)Reported Device Performance (ACS Digitoxin)
    SensitivityMinimum detectable concentration adequate for clinical useMeasures up to 80 ng/mL, with a minimum detectable concentration of 1.5 ng/mL
    Accuracy (Correlation to FPIA)Strong correlation to established method (Predicate Device: TDX Digitoxin Immunoassay, Abbott Laboratories)Correlation coefficient (r) = 0.83 (for 608 samples from 1.5 to 60 ng/mL)
    Accuracy (Linear Regression vs. FPIA)Linear relationship with a reasonable slope and interceptACS:180 Digitoxin = 0.79 (alternate method) + 4.9 ng/mL (for 608 samples from 1.5 to 60 ng/mL)

    Note: The document
    does not explicitly state "acceptance criteria" values for correlation coefficient, slope, or intercept. These are inferred from the presentation of the data as supporting the device's accuracy and substantial equivalence.

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

    • Sample Size for Test Set: 608 samples.
    • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a submission to the FDA, it's highly likely to be clinical samples, though the specifics are not provided.

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

    • This information is not provided in the document. The "ground truth" for the test set is established by the "alternate fluorescence polarization (FPIA) method," which is itself a diagnostic assay. The document doesn't detail the development or validation of this FPIA method.

    4. Adjudication Method for the Test Set

    • This information is not applicable/provided in the context of this type of analytical validation. The comparison is against an instrumental method (FPIA), not a human-adjudicated ground truth.

    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, an MRMC comparative effectiveness study was not done. This device is an automated immunoassay for measuring a chemical substance (digitoxin concentration) in serum/plasma, not an imaging device or a diagnostic tool requiring human interpretation or AI assistance in that sense.

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

    • Yes, the performance data presented is for the standalone algorithm (ACS Digitoxin immunoassay). The "accuracy" and "sensitivity" are inherent properties of the assay system itself, not dependent on human interpretation of the assay results in a "human-in-the-loop" setting.

    7. The Type of Ground Truth Used

    • The "ground truth" (or reference method) for the performance study was an alternate fluorescence polarization (FPIA) method. This is a laboratory diagnostic method.

    8. The Sample Size for the Training Set

    • The document does not specify a training set sample size. For an immunoassay, the "training set" concept is usually associated with the development and calibration of the assay itself, not a separate, explicitly defined "training set" as might be seen in machine learning applications. The 608 samples are described as involved in the "accuracy" study comparing to the alternate method.

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

    • As a "training set" is not explicitly defined or described in the context of this submission, the method for establishing its "ground truth" is not provided. The FPIA method serves as the reference standard for the performance evaluation.
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