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510(k) Data Aggregation

    K Number
    K013128
    Device Name
    N LATEX LP(A)
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2002-01-18

    (121 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K000121
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    Device Name :

    N LATEX LP(A)

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

    N Latex Lp(a) Reagent is an in vitro diagnostic test for the quantitative determination of Lipoprotein(a) [Lp(a)] in human serum or plasma. N Latex Lp(a) aids in the diagnosis of disorders of lipid (fat) metabolism and helps to identify persons at risk from cardiovascular disease in specific populations when used in conjunction with clinical evaluation.

    Device Description

    Polystyrene latex particles coated with specific antibodies to human Lp(a) are agglutinated when mixed with samples containing Lp(a). The intensity of scattered light in the BN™ Systems depends on the Lp(a) concentration in the sample. The concentration can therefore be determined by comparison with dilutions of a standard of known concentration.

    AI/ML Overview

    Acceptance Criteria and Device Performance Study for N Latex Lp(a) Reagent

    This report details the acceptance criteria and the study conducted to demonstrate the performance of the N Latex Lp(a) Reagent, based on the provided 510(k) summary.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria (Implicit)Reported Device Performance
    CorrelationStrong positive correlation (e.g., r > 0.90) with a legally marketed predicate device. Slope close to 1, y-intercept close to 0.Correlation coefficient: 0.96 (with Beckman Coulter Array® System LPA assay)
    Y-intercept: -0.005
    Slope: 0.92 (Passing-Bablok)
    Precision (Intra-assay)Low coefficient of variation (CV%) for repeated measurements within the same assay (e.g.,
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