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510(k) Data Aggregation

    K Number
    K964660
    Device Name
    PARAMAX CHOLESTEROL REAGENT
    Manufacturer
    DADE INTL., INC.
    Date Cleared
    1997-06-04

    (196 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PARAMAX CHOLESTEROL REAGENT

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

    For quantitative determination of cholesterol or HDL cholesterol in plasma or serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders'.

    Device Description

    The Paramax® Cholesterol Reagent and DuPont aca Cholesterol Reagent are based on colormetic methodology.

    AI/ML Overview

    The Paramax® Cholesterol Reagent demonstrated substantial equivalence to the DuPont aca Cholesterol Reagent through a correlation study.

    1. Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance (Paramax® vs. DuPont aca)
    Cholesterol: Correlation as demonstrated by a strong correlation coefficient and a regression equation indicating similar values.Correlation Coefficient: 0.984
    Regression Equation: Paramax® value = (1.10 * aca value) - 7.1
    HDL Cholesterol: Correlation as demonstrated by a strong correlation coefficient and a regression equation indicating similar values.Correlation Coefficient: 0.9881
    Regression Equation: Paramax® value = (1.012 * aca value) - 2.27

    2. Sample Size and Data Provenance:

    • Cholesterol: 48 specimens
    • HDL Cholesterol: 100 specimens
    • Data Provenance: Not specified, but generally, such studies are retrospective using a collection of patient samples. The country of origin is not mentioned.

    3. Number of Experts and Qualifications:

    Not applicable. This study involves the comparison of reagent performance on quantitative measurements, not expert interpretation of diagnostic images or data.

    4. Adjudication Method:

    Not applicable. This is a quantitative comparison of two chemical assays, not a subjective interpretation requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    Not applicable. This is a comparison of two diagnostic reagents, not an AI-assisted human reader study.

    6. Standalone Performance:

    The provided information describes a comparative study between the Paramax® Cholesterol Reagent and a predicate device. While there isn't a separate "standalone" performance section explicitly detailing the Paramax®'s absolute accuracy against a gold standard in isolation, the comparison to a legally marketed predicate device is considered its standalone performance in a regulatory context for demonstrating substantial equivalence. The predicate device's performance would have been established independently.

    7. Type of Ground Truth:

    The ground truth is established by the measurements obtained from the predicate device, the DuPont aca Cholesterol Reagent. In essence, the predicate device serves as the reference standard against which the new device is compared. This type of ground truth can be considered a "reference method" comparison or "device-to-device" comparison.

    8. Sample Size for the Training Set:

    Not applicable. This is a validation study comparing two established methodologies/reagents, not a machine learning model requiring a training set.

    9. How the Ground Truth for the Training Set was Established:

    Not applicable, as there is no training set for this type of validation study.

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