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510(k) Data Aggregation

    K Number
    K012152
    Device Name
    DS30 HCY BLOOD COLLECTION TUBES
    Manufacturer
    DREW SCIENTIFIC LTD.
    Date Cleared
    2001-09-18

    (69 days)

    Product Code
    GIM
    Regulation Number
    862.1675
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DS30 HCY BLOOD COLLECTION TUBES

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

    Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor) for the collection and stabilization of 2.5 mL whole blood prior to removal of plasma for total homocysteine measurement by HPLC for the detection of hyperhomocysteinæmia.
    prescription use

    Device Description

    Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a blood collection tube (DS30 Hcy Blood Collection Tubes). It does not contain information on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies typically associated with AI/ML-based medical devices or comparative effectiveness studies.

    Therefore, I cannot fulfill the request as the provided document focuses on regulatory clearance for a blood specimen collection device and does not detail a study involving the criteria mentioned.

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