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510(k) Data Aggregation

    K Number
    K992244
    Device Name
    GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE
    Manufacturer
    GREINER MEDITECH, INC.
    Date Cleared
    1999-07-26

    (24 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K971221
    Why did this record match?
    Device Name :

    GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE

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

    The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a 3.2% sodium citrate solution, intended to collect, transport, and process whole blood for coagulation testing.
    The MiniCollect® Coagulation tube is intended for citrate anticoagulated whole blood samples for Coagulation Assays.

    Device Description

    The Greiner MiniCollect® is a non-sterile, non-evacuated blood collection device containing a 3.2% sodium citrate solution, intended to collect, transport, and process whole blood for coagulation testing.

    AI/ML Overview

    The provided text is a 510(k) summary for the Greiner MiniCollect® Coagulation tube. It focuses on demonstrating substantial equivalence to a predicate device, the Greiner VACUETTE® Coagulation tube (K971221). The primary method of demonstrating this equivalence is through a comparative study of assay results using paired samples.

    Here's an analysis of the provided information against your requested criteria:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Stated or Implied)Reported Device Performance
    Primary Goal: Substantial Equivalence to predicate device (Greiner VACUETTE® Coagulation tube)."The equivalence of assay results for both tubes was evaluated by testing paired samples collected in Greiner MiniCollect® Coagulation tubes and Greiner VACUETTE® Coagulation tubes."
    Implied Performance: The study results supported the claim of substantial equivalence, as the device was cleared by the FDA. Specific numerical performance metrics (e.g., correlation coefficients, mean differences within acceptable ranges) are not provided in this summary.
    Intended Use: Collection, transport, and processing of whole blood for coagulation testing.The device meets this intended use, as verified by the FDA's clearance.

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

    • Sample Size: The document does not explicitly state the number of paired samples used in the equivalence study. It only mentions "testing paired samples."
    • Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

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

    This type of information is not relevant or typically provided for a device like a blood collection tube. The "ground truth" here is the assay results themselves, which are generated by laboratory instruments, not by expert interpretation.

    4. Adjudication Method for the Test Set

    Not applicable for this type of device and study. The comparison is between quantitative assay results, not subjective interpretations requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

    No, this was not an MRMC comparative effectiveness study. This type of study is used to evaluate the impact of a device or algorithm on human reader performance, typically in diagnostic imaging. The Greiner MiniCollect® is a blood collection tube, and its evaluation focuses on analytical performance.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    Yes, in a sense, the primary study was a "standalone" evaluation of the device's impact on assay results, independent of human interpretation or human-in-the-loop involvement during the device's operation (i.e., the tube itself doesn't have an algorithm). The performance being assessed is the analytical performance of the tube in preserving blood quality for coagulation testing.

    7. The Type of Ground Truth Used

    The ground truth was established by analytical results from standard coagulation assays performed on blood collected in the predicate device (Greiner VACUETTE® Coagulation tube). The paired samples allowed for a direct comparison of the tested device against an established, legally marketed standard.

    8. The Sample Size for the Training Set

    Not applicable. This device does not involve machine learning or algorithms that require a "training set." The study evaluated the physical characteristics and chemical properties of the tube and its effect on blood samples.

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

    Not applicable, as there is no training set for this device.

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