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510(k) Data Aggregation

    K Number
    K972969
    Device Name
    QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
    Manufacturer
    INNOVATIVE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-09-22

    (42 days)

    Product Code
    GIO,JKA
    Regulation Number
    864.6150
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    GIO

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

    The Quick-Draw Capillary Whole Blood Collection System is intended for in vitro diagnostic use to facilitate the collection of whole blood specimens from a capillary puncture site, i.e., finger or heel stick. The system is composed of the Quick-Draw collector with a collection tube attached. The Quick-Draw collector is attached to the Quick-Draw Handle, a battery operated vacuum device. When assembled and activated, the system aspirates blood specimens from the puncture site into the collection tube.

    Device Description

    The Quick-Draw Capillary Whole Blood Collection System is intended for in vitro diagnostic use to facilitate the collection of whole blood specimens from a capillary puncture site, i.e., finger or heel stick. The system is composed of the Quick-Draw collector with a collection tube attached. The Quick-Draw collector is attached to the Quick-Draw Handle, a battery operated vacuum device. When assembled and activated, the system aspirates blood specimens from the puncture site into the collection tube.

    AI/ML Overview

    I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "Quick-Draw Capillary Whole Blood Collection System." This document primarily focuses on regulatory approval and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

    Specifically, the text does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Information on experts used to establish ground truth or their qualifications.
    4. Adjudication methods.
    5. Details about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
    6. Information on standalone algorithm performance.
    7. The type of ground truth used (e.g., pathology, outcomes data).
    8. Sample size for a training set.
    9. How ground truth for the training set was established.

    This document confirms regulatory clearance based on substantial equivalence to a predicate device, but it does not detail the specific performance studies that would typically be conducted to demonstrate the device meets acceptance criteria. Those details would normally be found in the 510(k) submission itself, not in the clearance letter.

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