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510(k) Data Aggregation

    K Number
    K973464
    Device Name
    QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL)
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    1997-10-22

    (40 days)

    Product Code
    DHR
    Regulation Number
    866.5775
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K896271
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic test for use with automated instrumentation in the quantitative determination of human rheumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of theumatoid arthritis.

    Device Description

    Biokit's quantex RF plus (latex, buffer, standard, control) is an in vitro diagnostic product for use with automated instrumentation in the quantitative determination of human theumatoid factors in serum by turbidimetric immunoassay and is intended as an aid in the diagnosis of Rheumatoid Arthritis.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the quantex RF plus device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryAcceptance Criteria (Explicit or Implied)Reported Device Performance
    Method Comparison/CorrelationSubstantial equivalence in performance to the predicate device, implying strong correlation between the new device and the predicate device across different automated instrumentation with extended analysis range (0-200 IU/mL). (Implied: High correlation coefficient (r))Monarch: r = 0.992 (with n=152 samples)
    Hitachi: r = 0.995 (with n=175 samples)
    Cobas Mira: r = 0.990 (with n=261 samples)
    Precision (Within Run CV)Within run coefficient of variation (CVs)
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