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    K Number
    K970314
    Device Name
    SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-04-21

    (87 days)

    Product Code
    MSJ
    Regulation Number
    862.1475
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K862019,K862386
    Why did this record match?
    Device Name :

    SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS

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

    The SYNCHRON LX Systems Apolipoprotein A-1 (ApoA) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein A-1 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 Apolipoprotein B (ApoB) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein B 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 Apolipoprotein ApoA and ApoB Reagents in conjunction with SYNCHRON Systems APO CAL, are intended for use on Beckman's SYNCHRON LX Clinical Systems.

    AI/ML Overview

    The provided text describes the SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents. It details method comparison studies, imprecision data, and stability information. However, it does not explicitly state specific acceptance criteria in a quantifiable fashion that the device must meet. Instead, it presents performance data and implies that this data demonstrates substantial equivalence to predicate devices.

    Therefore, I cannot fully complete the table for "Acceptance Criteria" as it is not explicitly provided in the document in a numerical, predefined target format. I will fill in the "Reported Device Performance" based on the study results.

    Here is an analysis based on the information provided:

    1. Table of (Implicit) Acceptance Criteria and Reported Device Performance

    As stated, explicit numerical acceptance criteria are not presented in the document. The document's purpose is to demonstrate substantial equivalence to predicate devices and generally acceptable performance for in vitro diagnostic devices. The reported device performance is from method comparison and imprecision studies.

    Performance MetricImplied Acceptance Criteria (Based on general IVD expectations & predicate comparison)Reported Device Performance (SYNCHRON LX™ Systems)
    Method Comparison (vs. Beckman Predicate)
    ApoA SlopeClose to 1.00.953
    ApoA Intercept (mg/dL)Close to 04.1
    ApoA Correlation Coefficient (r)High (e.g., >0.95)0.9922
    ApoB SlopeClose to 1.00.943
    ApoB Intercept (mg/dL)Close to 07.6
    ApoB Correlation Coefficient (r)High (e.g., >0.95)0.9970
    Method Comparison (vs. NWLRL Nephelometric Procedure)
    ApoA SlopeClose to 1.01.022
    ApoA Intercept (mg/dL)Close to 0-3.4
    ApoA Correlation Coefficient (r)High (e.g., >0.95)0.965
    ApoB SlopeClose to 1.01.006
    ApoB Intercept (mg/dL)Close to 01.7
    ApoB Correlation Coefficient (r)High (e.g., >0.95)0.991
    Imprecision (ApoA %C.V.)
    ApoA Level 1Low (e.g.,
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