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    K Number
    K972495
    Device Name
    ACCUMETER THEOPHYLLINE TEST
    Manufacturer
    CHEMTRAK, INC.
    Date Cleared
    1997-10-10

    (99 days)

    Product Code
    KLS
    Regulation Number
    862.3880
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K932127
    Why did this record match?
    Device Name :

    ACCUMETER THEOPHYLLINE TEST

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

    The ChemTrak AccuMeter® Theophylline Test provides a rapid, noninstrumented enzyme immunochromatographic method for in vitro quantitative measurement of Theophylline concentrations in ambulatory patients using fingerstick whole blood, heparinized venous whole blood or serum. This test has not been validated for use with blood from neonates.

    Device Description

    The AccuMeter Theophylline Test is a rapid immunoassay for the quantitative detection of theophylline, using HRP labeled anti-theophylline antibodies and immobilized monoclonal anti-theophylline antibodies. The immunospecific signal is measured by the height of the enzyme label along the test strip.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Metric (Implied)Reported Device Performance
    Accuracy (Correlation to Predicate)Correlation Coefficient (R) for AccuMeter Fingerstick vs. TDx0.943 (from Table 1, "AccuMeter Compared to TDx Theophylline" for 102 observations) and 0.937 (from Table 2, "AccuMeter Fingerstick vs TDx" for 40 observations).
    Correlation Coefficient (R) for AccuMeter Serum vs. TDx0.959 (from Table 2, "AccuMeter Serum vs TDx" for 39 observations)
    Correlation Coefficient (R) for AccuMeter Whole Blood vs. TDx0.963 (from Table 2, "AccuMeter Whole Blood vs TDx" for 39 observations)
    PrecisionWithin-Run % CV (Coefficient of Variation)Level 1: 5.9% (Study 1), 7.7% (Study 2), 7.5% (Study 3)
    Level 2: 6.0% (Study 1), 6.0% (Study 2), 4.7% (Study 3)
    Total % CV (Coefficient of Variation)Level 1: 7.6% (Study 1), 7.8% (Study 2), 10.7% (Study 3)
    Level 2: 6.7% (Study 1), 7.6% (Study 2), 8.4% (Study 3)
    SensitivityLower Limit of Detection5 ug/mL (The assay is sensitive enough to detect down to 5 ug/mL. Results
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