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510(k) Data Aggregation

    K Number
    K072548
    Manufacturer
    Date Cleared
    2008-04-18

    (221 days)

    Product Code
    Regulation Number
    862.1215
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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

    The Teco Diagnostics Creatine Kinase liquid reagent is intended for in vitro diagnostic test for the quantitative determination of creatine kinase activity in human serum. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

    Device Description

    Creatine Kinase Liquid Reagent (Kinetic Method)

    AI/ML Overview

    {
    "1. A table of acceptance criteria and the reported device performance": null,
    "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
    "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": null,
    "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
    "5. 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": null,
    "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
    "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
    "8. The sample size for the training set": null,
    "9. How the ground truth for the training set was established": null
    }

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