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510(k) Data Aggregation

    K Number
    K964767
    Device Name
    QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(
    Manufacturer
    R & D SYSTEMS, INC.
    Date Cleared
    1997-05-29

    (183 days)

    Product Code
    JZG
    Regulation Number
    866.5630
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Quantikine IVD β,-microglobulin EIA kit is intended for the quantitative determination of β, microglobulin concentration in human serum and urine as an aid in the diagnosis of active rheumatoid arthritis and kidney diseases.

    Device Description

    The product is a competitive binding enzyme immunoassay (EIA) for ß2 microglobulin.

    AI/ML Overview

    The provided text describes the acceptance criteria and performance of the Quantikine™ IVD™ ß2 microglobulin enzyme immunoassay.

    Here's the breakdown of the information requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Signal generated by standard 0 to be greater than 1.5 absorbance unitsNot explicitly stated, but implied to be met for device approval.
    Signal generated by standard 5 to be less than 0.35 absorbance unitsNot explicitly stated, but implied to be met for device approval.
    Curve fitting individual replicates of Standard 1 to fit within ±15% of nominal value and the Mean value of Standard 1 to fit within ±10% of nominal value. Individual replicates and Mean values of Standards 2-5 to fit within ± 10% of nominal value.Not explicitly stated, but implied to be met for device approval.
    In-house control and kit control values to be within the ranges quoted on the appropriate control data sheets.Not explicitly stated, but implied to be met for device approval.
    Sensitivity to be less than 0.2 µg/mL.**
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