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510(k) Data Aggregation

    K Number
    K964791
    Device Name
    B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
    Manufacturer
    BAYER CORP.
    Date Cleared
    1997-05-29

    (181 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

    This in vitro diagnostic method is intended to quantitatively measure the concentration of B2-microglobulin in human serum and urine using the Technicon Immuno 1® system. B2-Microglobulin assay values obtained should be used in conjunction with information available from clinical and other diagnostic procedures in the management of patients with renal dysfunction and rheumatoid arthritis. This diagnostic method is not intended for use on any other system.

    Device Description

    This is an in vitro, solid-phase enzyme immunoassay for the quantitative measurement of beta-2-Microglobulin in serum and urine.

    AI/ML Overview

    The Acceptance Criteria and Study for the Beta-2-Microglobulin Method for Bayer Technicon Immuno 1® System are detailed below:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state acceptance criteria in a dedicated section. However, it presents performance characteristics of the Immuno 1 beta-2-Microglobulin method and compares them to those of the predicate device (Abbott IMX beta-2-Microglobulin Assay). The "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device and meeting general performance expectations for such assays.

    Performance MetricAcceptance Criteria (Implied by Predicate Device/General Expectation)Reported Device Performance (Immuno 1 beta-2-Microglobulin)Conclusion
    Minimum Detectable Conc.Comparable to predicate device (Abbott IMX: 0.005 mg/L)0.01 mg/LDeemed acceptable for intended use, though slightly higher than predicate.
    Precision (Within-Run)Comparable to predicate device (Abbott IMX: Serum 4.4-6.0%, Urine 4.7-5.5%)SERUM: 1.79%, 1.25%, 1.89%
    URINE: 1.48%, 1.10%, 4.98%Better than or comparable to predicate device.
    Correlation (Serum)Strong correlation with predicate device (Abbott IMX)y=0.99x+0.11, r=0.99, Syx=0.93 mg/L (n=97)Strong correlation.
    Correlation (Urine)Strong correlation with predicate device (Abbott IMX)y=1.05x-0.05, r=0.99, Syx=0.52 mg/L (n=24)Strong correlation.
    InterferencesBeta-2-Microglobulin recoveries within acceptable range (not explicitly defined, but shown in Table 3)Recoveries for spiked interferants are shown in Table 3. Generally, values are close to the unspiked sample.Appears acceptable, no significant interferences reported.
    Sample DilutionCalculated concentrations should be close to measured concentrations (low deviation %)Deviations vary but are generally within acceptable limits for a quantitative assay (Tables 4-7, e.g.,
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