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    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
    Why did this record match?
    Device Name :

    ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650

    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
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