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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 < 5% for assays.Within-run Precision (CV):- Mean Plasminogen 49%: 1.9%- Mean Plasminogen 96%: 1.5%

    Additional Study Information:

    1. Sample sizes used for the test set and the data provenance:

      • ACL 300: n=59
      • Cobas Mira S: n=41
      • Cobas Bio: n=30
      • Cobas Fara: n=30
      • EPOS 5060: n=32
      • MLA: n=37
      • Test tube method: n=23
      • Microplate method: n=31
      • Precision study: Not explicitly stated, but includes data points for mean plasminogen concentrations of 49% and 96% over "multiple runs."
      • Data Provenance: Not explicitly stated (e.g., country of origin). The study design appears to be a prospective comparison of samples measured by both devices, given it's a "method comparison study."

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
      This is an in vitro diagnostic device for quantitative determination of plasminogen activity. The "ground truth" for the test set is established by the measurements obtained from the predicate device (Coatest® Plasminogen), which is a previously cleared and accepted test. Therefore, it does not rely on expert interpretation or consensus in the same way an imaging or diagnostic AI device might.

    3. Adjudication method for the test set:
      Not applicable. The study compares quantitative measurements between two laboratory devices, not subjective interpretations requiring adjudication.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
      Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
      Yes, the study presents the performance of the Coamatic® Plasminogen device as a standalone analytical instrument. The correlation and precision data reflect the algorithm's (or device's) performance in determining plasminogen levels.

    6. The type of ground truth used:
      The ground truth for this method comparison study is the results obtained from the predicate device, Coatest® Plasminogen. The goal is to demonstrate substantial equivalence, meaning the new device provides comparable results to an already accepted device.

    7. The sample size for the training set:
      Not specified. Given this is a comparison of an in vitro diagnostic assay with a predicate, rather than an AI/ML model, there isn't typically a "training set" in the sense of machine learning. The device's reagents and methodology would have been developed and optimized, but the sample sizes for that development are not detailed here.

    8. How the ground truth for the training set was established:
      Not applicable, as a separate "training set" with ground truth in the context of machine learning is not described. The device's analytical performance relies on its chemical and enzymatic reactions, which are validated against a known standard (the predicate device in this case, and presumably internal standards during development).

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