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510(k) Data Aggregation

    K Number
    K965108
    Device Name
    SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-03-06

    (76 days)

    Product Code
    DEW
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K771603
    Why did this record match?
    Device Name :

    SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT

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

    The SYNCHRON LX Systems Immunoglobulin G (Ig-G) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin G in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

    The SYNCHRON LX Systems Immunoglobulin A (Ig-A) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin A in serum or plasma. This assay is designed for use with dinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

    The SYNCHRON LX Systems Immunoglobulin M (Ig-M) reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human immunoglobulin M in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

    Device Description

    The SYNCHRON LX™ Systems Immunoglobulin G, A, and M (Ig-G, Ig-A, Ig-M) Reagents in conjunction with SYNCHRON LX Calibrator 1, are intended for use on Beckman's SYNCHRON LX Clinical Systems.

    AI/ML Overview

    The provided 510(k) summary describes the SYNCHRON LX™ Systems Immunoglobulin G, A, & M Reagents. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The performance data focuses on method comparison, imprecision, and stability studies.

    Here's an analysis of the acceptance criteria and study data based on your request:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" for performance metrics in a formal, separate table. However, equivalence is demonstrated by comparing the new device's performance to the predicate devices through method comparison studies. The implicit acceptance criteria for method comparison would be a strong correlation (r-value close to 1) and a slope close to 1 with an intercept close to 0, indicating a close agreement with the predicate. For imprecision, lower Coefficients of Variation (CV%) indicate better precision. Stability claims are also presented, which serve as performance claims that must be met.

    Performance MetricAcceptance Criteria (Implicit from Equivalence)Reported Device Performance (SYNCHRON LX™ Reagents)
    Method Comparison
    Ig-G Reagent: SlopeClose to 1.00.928
    Ig-G Reagent: InterceptClose to 072.7
    Ig-G Reagent: rClose to 1.0 (e.g., >0.95 or >0.98)0.9970
    Ig-A Reagent: SlopeClose to 1.00.924
    Ig-A Reagent: InterceptClose to 00.68
    Ig-A Reagent: rClose to 1.0 (e.g., >0.95 or >0.98)0.9962
    Ig-M Reagent: SlopeClose to 1.01.051
    Ig-M Reagent: InterceptClose to 0-17.19
    Ig-M Reagent: rClose to 1.0 (e.g., >0.95 or >0.98)0.9914
    Imprecision (Ig-M)Low %CV (e.g.,
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