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510(k) Data Aggregation

    K Number
    K050266
    Device Name
    DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR
    Manufacturer
    STANBIO LABORATORY
    Date Cleared
    2005-06-30

    (146 days)

    Product Code
    JFM
    Regulation Number
    862.1110
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K910593,K910591
    Why did this record match?
    Device Name :

    DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR

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

    The Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® test systems are devices intended to measure the levels of bilirubin (direct and total) in serum and plasma. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

    Device Description

    The Direct Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. The Total Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® devices, based on the provided 510(k) summary:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryReported Device Performance (Direct Bilirubin)Reported Device Performance (Total Bilirubin)
    Precision (Intra-assay)CV ≤ 3.12% (n=20)CV ≤ 3.05% (n=20)
    Precision (Inter-assay)CV ≤ 3.34% (n=20)CV ≤ 3.49% (n=20)
    Correlation (vs. predicate)r = 0.995 (y = 0.9394x - 0.06 mg/dL)r = 0.999 (y = 1.0108x - 0.0145 mg/dL)
    Sensitivity0.1 mg/dL per 0.001 absorbance units0.07 mg/dL per 0.001 absorbance units
    Linearity0.1 to 10 mg/dL0.07 to 30 mg/dL
    Comparison (Plasma vs. Serum)r = 0.9999 (y = 1.0118x - 0.0078)r = 0.9995 (y = 1.02x - 0.006)

    Note: The document does not explicitly state numerical acceptance thresholds for each criterion but presents the results of the performance studies. It is implied that these reported performance metrics were considered acceptable for demonstrating substantial equivalence. For instance, the high correlation coefficients (r) suggest strong agreement with the predicate devices, which is a common acceptance criterion for equivalence in such tests.

    Study Details

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

      • Direct Bilirubin Test Set:
        • Correlation: 85 samples.
        • Comparison (Plasma vs. Serum): 22 samples.
        • Precision (Intra-assay & Inter-assay): n=20 for each sample level tested.
      • Total Bilirubin Test Set:
        • Correlation: 247 samples.
        • Comparison (Plasma vs. Serum): 19 samples.
        • Precision (Intra-assay & Inter-assay): n=20 for each sample level tested.
      • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that these are in vitro diagnostic devices for measuring analytes in human samples, the samples would typically be human serum or plasma.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are quantitative assays for chemical analytes, not image-based or clinical diagnostic tests requiring expert interpretation to establish ground truth in the traditional sense. The "ground truth" for the correlation and comparison studies is established by the results from a "commercially available test" (Roche Direct Bilirubin/Total Bilirubin tests).

    3. Adjudication method for the test set: Not applicable. No human interpretation or adjudication process is involved in determining the "ground truth" for these types of quantitative assays.

    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 an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers.

    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance data (precision, sensitivity, linearity) represents standalone performance, as it is a fully automated/instrument-based chemical assay. The "correlation" and "comparison" studies are essentially comparisons of the new device's standalone performance against another commercially available standalone device.

    6. The type of ground truth used:

      • For Correlation studies, the ground truth was established by the measurements obtained from the predicate devices: Roche Direct Bilirubin (K910593) and Roche Total Bilirubin (K910591).
      • For Precision, Sensitivity, and Linearity, the ground truth is effectively the expected chemical value of the calibrators and samples used in the study, and the assessment is of the device's ability to consistently and accurately measure those values.

    7. The sample size for the training set: Not applicable. This is a chemical assay, not an machine learning/AI model that requires training data.

    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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