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510(k) Data Aggregation

    K Number
    K061382
    Device Name
    ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2006-07-06

    (49 days)

    Product Code
    JZO,JIT
    Regulation Number
    866.5870
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    k991096
    Predicate For
    K240469
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems.

    The detection of TPO antibodies is an aid in the diagnosis of thyroid autoimmune disorders.

    Device Description

    The Access TPO Antibody reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC 600i, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the determination of thyroperoxydase antibody (TPO) levels in human serum and plasma.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the provided device, based on the input text:

    Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device PerformanceStudy Type
    Imprecision (Within-run CV)Ranged from 2.6% CV to 7.9% CV for concentrations from approximately 0.6 to 809 IU/mL.Analytical Study
    Imprecision (Between-run CV)Ranged from 1.3% CV to 4.9% CV.Analytical Study
    Imprecision (Total CV)Ranged from 3.1% CV to 8.7% CV.Analytical Study
    Dilution Recovery (Linearity)Mean % recovery ranged from 86.4% to 94.9%. Note: "Due to varying antigen specificity, and avidity of TPOAb in their epitope reactions, some samples may not dilute linearly."Analytical Study
    Methods Comparison (Against a commercially available immunoassay system)Range of observations: 5-1000Slope: 1.0207 (95% confidence interval 0.9722 to 1.0693)Intercept: -10.9123 (95 % confidence interval -24.6421 to 2.8175)Correlation coefficient (r): 0.97Results indicate the slope and intercept are not significantly different from one and zero respectively.Analytical Study
    Analytical Specificity (Interference from potential sample contaminants)No significant interference from bilirubin, hemoglobin, human serum albumin, and triglycerides.Analytical Study
    Stability (TPOAb reagents)Stable for 56 days after opening.Analytical Study
    Stability (TPOAb calibrators)Stable for 120 days after opening.Analytical Study
    Stability (Calibration)Stable for 56 days.Analytical Study
    Expected/Normal Reference Range (Healthy males <30 years)Upper reference limit below 9 IU/mL (95% non-parametric determination).Clinical Study
    Expected/Normal Reference Range (Normal population 18-80 years with specific screening criteria)93% of samples fell below 9 IU/mL (out of 492 tested).Clinical Study
    Clinical Sensitivity (Hashimoto's Thyroiditis patients)100% of 54 patients tested positive.Clinical Study
    Clinical Sensitivity (Graves' Disease patients)77.5% of 40 patients tested positive.Clinical Study

    Study Details

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

      • Imprecision: Not explicitly stated as a single "test set" sample size but tested across concentrations from approximately 0.6 to 809 IU/mL. Data provenance not specified.
      • Dilution Recovery (Linearity): "Multiple dilutions of serum samples were analyzed." Specific sample size not given. Data provenance not specified.
      • Methods Comparison: 119 values. Data provenance not specified.
      • Analytical Specificity: Not specified. Data provenance not specified.
      • Stability: Specific sample sizes not given for stability testing. Data provenance not specified.
      • Expected Values:
        • Healthy male population <30 years: Sample size not explicitly stated for the primary reference range establishment, but criteria outlined by NACB were followed. Data provenance: United States.
        • Normal population (18-80 years): 679 normal samples collected, with 492 samples ultimately tested after screening. Data provenance: United States.
      • Clinical Sensitivity:
        • Hashimoto's Thyroiditis: 54 patients. Data provenance not specified.
        • Graves' Disease: 40 patients. Data provenance not specified.

    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 an immunoassay designed to quantitatively measure a biomarker. "Ground truth" is based on the chemical measurement itself and comparison to established reference methods or clinical diagnosis. Clinical diagnoses (Hashimoto's Thyroiditis, Graves' Disease) forming the basis for clinical sensitivity would have been made by medical professionals, but the number and qualifications are not detailed here.

    3. Adjudication method for the test set: Not applicable for a quantitative immunoassay. Test results are numerical outputs directly from the device.

    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 device is an automated immunoassay, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, all analytical and clinical performance studies described are for the device (Access TPO Antibody assay on Access Immunoassay Systems) operating in a standalone, automated fashion without human intervention in the result determination process itself. Human involvement is in sample collection, running the assay, and interpreting the results in a clinical context.

    6. The type of ground truth used:

      • Analytical Studies: Ground truth is based on established laboratory methodologies and expected performance characteristics for assays (e.g., linearity, precision, recovery, non-interference). For method comparison, the "ground truth" is the result from the predicate or commercially available immunoassay system.
      • Clinical Studies:
        • Expected Values: Clinical criteria for healthy individuals, including TSH levels and absence of thyroid/autoimmune disease, defined the "normal" ground truth. For the <30 age group, NACB criteria were used.
        • Clinical Sensitivity: Clinical diagnosis of Hashimoto's Thyroiditis and Graves' Disease by medical professionals served as the ground truth.

    7. The sample size for the training set: Not applicable in the context of machine learning or AI. This is a traditional immunoassay, not an algorithm that has a "training set" in that sense. The assay is developed and validated, but it doesn't "learn" from a training set in the way an AI model does.

    8. How the ground truth for the training set was established: Not applicable, as there is no "training set" for this type of device.

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