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510(k) Data Aggregation

    K Number
    K991120
    Device Name
    VACUTAINER BRAND CTAD TUBE (MULTIPLE)
    Manufacturer
    BECTON DICKINSON VACUTAINER SYSTEMS
    Date Cleared
    1999-05-19

    (47 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VACUTAINER® Brand CTAD Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. The CTAD additive, a combination of a buffered sodium citrate, theophylline, adenosine and dipyridamole, provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.

    Device Description

    The VACUTAINER® Brand CTAD Tubes are sterile, glass, evacuated blood collection tubes. The tubes contain 0.109M Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. In addition to citrate, the CTAD tube contains theophylline, adenosine and dipyridamole (inhibitors of platelet activation). The specimen is centrifuged and the plasma portion is analyzed for coagulation parameters to detect clotting time disorders and to monitor patients undergoing anticoagulation therapy.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested structure:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document describes a comparison study rather than setting explicit numerical acceptance criteria for a new device. The "performance" is reported as demonstrating clinical equivalence or superior performance in specific contexts.

    Acceptance Criteria (Inferred)Reported Device Performance
    Normal Donors: Clinical equivalence in coagulation parameters compared to the predicate device.The VACUTAINER® Brand CTAD Tube provided clinically equivalent results.
    Warfarin Donors: Clinical equivalence in coagulation parameters compared to the predicate device.The VACUTAINER® Brand CTAD Tube provided clinically equivalent results.
    Heparin Donors: Demonstrate the effects of the CTAD additive to prevent platelet activation and subsequent release of platelet factor 4, leading to more accurate monitoring of anticoagulant therapy.The VACUTAINER® Brand CTAD Tube demonstrated clinically non-equivalent aPTT, Heparin Xa, and Platelet Factor 4 results. This indicates superior performance by minimizing heparin neutralization due to platelet activation, leading to longer aPTT clotting times, higher Heparin Xa results, and lower Platelet Factor 4 results.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not explicitly stated. The document refers to "Normal Donors," "Warfarin Donors," and "Heparin Donors," implying multiple participants in each group, but the exact count is not provided.
    • Data Provenance: Not explicitly stated. There is no mention of the countries of origin for the data or whether it was prospective or retrospective.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This information is not provided in the document. The study compares two blood collection tubes; the "ground truth" here would likely be the actual coagulation parameters measured, rather than interpretations requiring expert consensus.

    4. Adjudication Method for the Test Set

    This information is not provided in the document. Given the nature of comparing laboratory results from blood samples, an adjudication method in the traditional sense (e.g., for image interpretation) is unlikely to be applicable.

    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

    A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a blood collection tube, not an AI-powered diagnostic tool, so "human readers" and "AI assistance" are not applicable.

    6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

    A standalone performance study was not done in the context of an algorithm. This device is a medical device (blood collection tube) that is used by humans to collect samples for laboratory analysis.

    7. The Type of Ground Truth Used

    The ground truth used was laboratory analysis of coagulation parameters. The document mentions "coagulation parameters," "aPTT," "Heparin Xa," and "Platelet Factor 4 results," which are objective measures obtained from blood samples.

    8. The Sample Size for the Training Set

    This information is not applicable/not provided. This device is a physical medical device (blood collection tube), not an AI algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable/not provided. As above, this device does not involve a training set or AI model.

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