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510(k) Data Aggregation

    K Number
    K023840
    Device Name
    ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
    Manufacturer
    BAYER DIAGNOSTICS CORP.
    Date Cleared
    2003-01-07

    (50 days)

    Product Code
    CKB,JIX,JJY
    Regulation Number
    862.1020
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k023840
    Predicate For
    K030801,K030804
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to measure total and non-prostatic acid phosphatase concentrations in human serum.
    The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to quantitatively measure total and non-prostatic acid phosphatase concentration in human serum.

    Device Description

    The ADVIA 1650 acid phosphatase method measures total and non-prostatic acid phosphatase in serum by a colorimetric procedure published by Hillmann. Tartrate inhibits prostatic acid phosphatase, allowing for measurement of non-prostatic acid phosphatase. The prostatic acid phosphatase concentration can be manually calculated by determining the difference between total acid phosphatase and non-prostatic acid phosphatase.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA® 1650™ Acid Phosphatase assay, based on the provided text:

    Acceptance Criteria and Device Performance

    ParameterAcceptance Criteria (Implicit)Reported Device Performance
    Imprecision (Total ACP)Sufficiently low CV to ensure reliable results (no explicit criteria stated, but expected to be within industry standards for clinical assays).Level 1 (18.39 U/L): Within-Run CV: 3.0%, Total CV: 9.2% Level 2 (36.98 U/L): Within-Run CV: 2.2%, Total CV: 4.0% Level 3 (42.23 U/L): Within-Run CV: 1.9%, Total CV: 3.8%
    Imprecision (NpACP)Sufficiently low CV to ensure reliable results (no explicit criteria stated).Level 1 (10.01 U/L): Within-Run CV: 6.2%, Total CV: 9.2% Level 2 (24.50 U/L): Within-Run CV: 3.4%, Total CV: 4.8% Level 3 (28.88 U/L): Within-Run CV: 5.1%, Total CV: 7.0%
    Correlation (NpACP)Strong correlation with predicate device (e.g., R-value > 0.95, slope near 1, intercept near 0, given the stated bias).N = 64, Regression Equation: Y = 0.82x + 1.8, Syx = 2.56, R = 0.987. 95% CI for slope: 0.787 to 0.856 95% CI for intercept: 0.793 to 2.811
    Correlation (Total ACP)Strong correlation with predicate device (e.g., R-value > 0.95, slope near 1, intercept near 0, given the stated bias).N = 71, Regression Equation: Y = 0.76x + 0.91, Syx = 1.95, R = 0.993. 95% CI for slope: 0.7345 to 0.7781 95% CI for intercept: 0.189 to 1.627
    Interfering SubstancesInsignificant interference (e.g., % change within an acceptable clinical limit, typically < +/- 10% or clinically insignificant).Bilirubin (unconjugated, 6.25 mg/dL): -9.3% Bilirubin (conjugated, 6.25 mg/dL): -1.7% Hemoglobin (50 mg/dL): -8.8% Lipids (Triglycerides, 1000 mg/dL): +4.49%
    Analytical RangeClearly defined and clinically useful range.4 to 200 U/L Serum
    Minimum Detectable Concentration (MDC)Low enough for clinical utility and reporting (no explicit threshold, but expected to be below the analytical range).Total ACP = 1.98 U/L npACP = 2.22 U/L

    Note regarding Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for most of these parameters. However, in the context of a 510(k) submission, the "acceptance criteria" are implicitly met if the reported performance is demonstrated to be "substantially equivalent" to predicate devices and acceptable for the intended use in a clinical laboratory setting. The FDA's issuance of the 510(k) implies that the provided data was deemed acceptable.

    Study Details

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

      • Correlation (NpACP): N = 64 serum samples.
      • Correlation (Total ACP): N = 71 serum samples.
      • Imprecision: Not explicitly stated as a "test set" in the same way as correlation. Imprecision studies typically involve repeated measurements of control materials or pooled patient samples over several days. For MDC, 44 replicates over 11 days (22 runs) were used.
      • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full study report, but is not present in this summary.

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

      • This device is an in vitro diagnostic assay for measuring biomarkers, not an image-based or diagnostic interpretation device requiring expert review for ground truth. The "ground truth" for method comparison and imprecision studies relies on the established reference method (the predicate device for correlation) and the inherent chemical properties of the analytes. Therefore, this question is not directly applicable in the same way as it would be for AI-powered diagnostic tools. There would be no "experts" establishing ground truth in this context.

    3. Adjudication method for the test set:

      • Not applicable. As this is a quantitative chemical assay, the "adjudication" (if one could use that term) is based on the result from the predicate device and standard analytical chemistry principles, not expert consensus or review.

    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 a standalone in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.

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

      • Yes, this entire submission describes the standalone performance of the ADVIA 1650 Acid Phosphatase assay as a laboratory instrument. The performance metrics (imprecision, correlation, interference, analytical range, MDC) are all measures of the device's inherent analytical capabilities.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • For the correlation study, the "ground truth" was established by the predicate device (Roche Acid Phosphatase method on the Hitachi system). The ADVIA 1650's results were compared against this established method.
      • For imprecision, analytical range, and MDC, the "ground truth" is derived from standard analytical chemistry and metrology principles, using reference materials, control solutions, and repeated measurements.

    7. The sample size for the training set:

      • Not applicable. As an in vitro diagnostic assay using established chemical reactions (Hillmann colorimetric procedure), there is no 'training set' in the machine learning sense. The method's parameters are based on scientific principles and validated through the studies presented.

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

      • Not applicable, as there is no "training set" for this type of IVD device.
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