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510(k) Data Aggregation

    K Number
    K013359
    Device Name
    LP(A)-LATEX SEIKEN ASSAY KIT
    Manufacturer
    DENKA SEIKEN'S
    Date Cleared
    2002-03-08

    (149 days)

    Product Code
    DFC
    Regulation Number
    866.5600
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K982708
    Why did this record match?
    Device Name :

    LP(A)-LATEX SEIKEN ASSAY KIT

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

    The Lp(a)-Latex SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.

    Device Description

    The Lp(a)-Latex SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of Lipoprotein (a) in human serum and plasma. Antigen in the sample binds to the specific anti-Lp(a) antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on Hitachi 917 analyzer, with the magnitude of the change being proportional to the quantity of Lp(a) in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentrations.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for correlation coefficient, sensitivity, or precision. Instead, it presents the results of the performance studies and concludes that these findings demonstrate the device's "robustness and substantial equivalence to the predicate device."

    However, we can infer the implied acceptance criteria from the reported performance, which demonstrates that the device's performance is acceptable for its intended use, especially in comparison to the predicate device.

    Performance MetricImplied Acceptance Criteria (Inferred from Predicate Equivalence)Reported Device Performance (Lp(a)-Latex SEIKEN Assay)
    Correlation Coefficient (vs. Predicate)High correlation (e.g., >0.90)r = 0.919
    Precision (Medium Control %CV)Low %CV (e.g.,
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