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    K Number
    K974721
    Device Name
    UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
    Manufacturer
    BAYER CORP.
    Date Cleared
    1998-03-03

    (75 days)

    Product Code
    CGI
    Regulation Number
    862.1265
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

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

    This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol (uE¿) in human serum on the Bayer Immuno 1™ system. Measurements of uE, are used in evaluating fetal well-being by monitoring the level of the hormone derived from fetal-placental circulation.

    This diagnostic method is not intended for use on any other system.

    Device Description

    This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol in human serum on the Bayer Immuno 1 System.

    AI/ML Overview

    Here's an analysis of the provided text regarding the Bayer Immuno 1™ Unconjugated Estriol method, focusing on acceptance criteria and study details:

    Device: Bayer Immuno 1™ System Unconjugated Estriol Assay

    Predicate Device: Diagnostic Products Corporation (DPC) Coat-a-Count® Free Estriol RIA method

    1. Acceptance Criteria and Reported Device Performance

    The document presents performance data for the Bayer Immuno 1™ uEstriol method and compares it to the predicate DPC Coat-a-Count® Free Estriol RIA method. While explicit acceptance criteria (e.g., "must be less than X," "must be greater than Y") are not formally listed as such in the provided text, the implied acceptance criteria are that the new device's performance is comparable to or better than the predicate device across various metrics, demonstrating substantial equivalence.

    Table of Acceptance Criteria (Implied) and Reported Device Performance:

    Performance MetricImplied Acceptance Criteria (relative to predicate)Bayer Immuno 1™ uE3 Reported PerformanceDPC Coat-a-Count® Free Estriol RIA Reported Performance (Predicate)Meets Implied Criteria?
    Precision (within-run)Comparable or better %CV at various concentration levels.
    - 0.41 ng/mL equiv.%CV should be similar or lower than predicate.3.6%9.1% (for 0.74 ng/mL mean)Yes
    - 3.60 ng/mL equiv.%CV should be similar or lower than predicate.3.2%5.5% (for 2.9 ng/mL mean)Yes
    - 6.49 ng/mL equiv.%CV should be similar or lower than predicate.1.5%3.8% (for 7.9 ng/mL mean)Yes
    - 11.37 ng/mL equiv.%CV should be similar or lower than predicate.2.3%3.8% (for 12.2 ng/mL mean)Yes
    Precision (total)Comparable or better %CV at various concentration levels.
    - 0.41 ng/mL equiv.%CV should be similar or lower than predicate.4.9%21.2% (for 0.74 ng/mL mean)Yes
    - 3.60 ng/mL equiv.%CV should be similar or lower than predicate.3.4%9.3% (for 2.90 ng/mL mean)Yes
    - 6.49 ng/mL equiv.%CV should be similar or lower than predicate.2.3%9.9% (for 7.90 ng/mL mean)Yes
    - 11.37 ng/mL equiv.%CV should be similar or lower than predicate.2.7%8.0% (for 12.20 ng/mL mean)Yes
    Method ComparisonStrong correlation (r close to 1) and linear regression indicating agreement between methods.
    - Regression Equation(No explicit numerical criterion given, but substantial equivalence implies a strong linear relationship with minimal bias)y = 0.87x + 0.62N/A (predicate is 'x')Yes (implied)
    - Correlation Coefficient (r)Close to 1 (e.g., typically > 0.95 for good agreement).0.98N/AYes
    - Sy.x(No explicit numerical criterion, but a low value indicates good fit).1.23N/AYes (implied)
    Specificity (Cross-reactivity)Cross-reactivity with common interferents should be low and comparable to the predicate.
    - Estriol-3-sulfate% Cross-reactivity comparable to predicate.1.70%0.46%Comparable*
    - Estriol-3-(β-D-glucuronide)% Cross-reactivity comparable to predicate.1.60%0.26%Comparable*
    - Estriol-16-α-(β-D-glucuronide)% Cross-reactivity comparable to predicate.0.05%0.66%Yes
    - Estradiol% Cross-reactivity comparable to predicate.0.44%0.13%Comparable*
    - 16a-HydroxyestroneLow cross-reactivity.7.60%Not reported(No direct comparison)
    - Other compoundsLow or not detected cross-reactivity.Generally low or not detectedGenerally low or not detectedYes

    *Note on Specificity: For some compounds (e.g., Estriol-3-sulfate, Estriol-3-(β-D-glucuronide), Estradiol), the Bayer Immuno 1™ shows a higher cross-reactivity percentage than the DPC method. However, without explicit acceptance limits, and given that these values are still relatively low (mostly

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