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    K Number
    K972696
    Device Name
    IL TEST D-DIMER
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    1997-11-04

    (109 days)

    Product Code
    DAP
    Regulation Number
    864.7320
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K945642
    Why did this record match?
    Device Name :

    IL TEST D-DIMER

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

    IL Test™ D-Dimer permits the quantitative in vitro diagnostic determination of D-Dimer in human plasma by turbidimetry.

    Device Description

    The IL Test™ D-Dimer Latex Reagent is a suspension of latex particles coated with a monoclonal antibody specific for the D-Dimer domain included in fibrin soluble derivatives. When plasma containing D-Dimer is mixed with the D-Dimer Latex Reagent and Reaction Buffer, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of D-Dimer in the sample and is determined by measuring the decrease of the transmitted light caused by the aggregates (turbidimetric immunoassay).

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study details for the IL Test™ D-Dimer, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria (Implicitly based on predicate equivalence)Reported Device Performance (IL Test™ D-Dimer)
    Correlation to Predicater ≥ 0.95 (typical for method comparison studies)0.998 on ACL 6000 and ACL Futura
    Precision (CV)Generally
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