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510(k) Data Aggregation

    K Number
    K974711
    Device Name
    COAMATIC PLASMINOGEN
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    1998-05-01

    (135 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K854572
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Coamatic® Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen (Plg) activity in human citrated plasma on automated laboratory equipment and also using microplate and manual methods. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.

    Device Description

    Coamatic® Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen (Plg) activity in human citrated plasma on automated laboratory equipment and also using microplate and manual methods.

    AI/ML Overview

    The provided document describes the Coamatic® Plasminogen device, an in vitro diagnostic test for plasminogen activity. The study presented is a method comparison study between the new Coamatic® Plasminogen and the predicate device, Coatest® Plasminogen, rather than a separate device performance study with specific acceptance criteria that are explicitly stated in a table.

    However, based on the information provided, we can infer the acceptance criteria and then list the reported performance.

    Inferred Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance Criteria (Inferred)Reported Device Performance
    Method ComparisonStrong correlation (r) to predicate device, typically > 0.90 for quantitative assays, across various instruments and methods.Correlation (r) to Coatest® Plasminogen:
    • ACL 300 (n=59): 0.92
    • Cobas Mira S (n=41): 0.97
    • Cobas Bio (n=30): 0.97
    • Cobas Fara (n=30): 0.97
    • EPOS 5060 (n=32): 0.99
    • MLA (n=37): 0.98
    • Test tube method (n=23): 0.92
    • Microplate method (n=31): 0.93 |
      | Precision (Within-run) | Low Coefficient of Variation (CV) for reproducibility, typically
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