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510(k) Data Aggregation

    K Number
    K994045
    Device Name
    PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
    Manufacturer
    PRIMUS CORP.
    Date Cleared
    1999-12-21

    (22 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Special
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2

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

    In vitro diagnostic use to establish reference points for glycated hemoglobin test methods

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "Primus Liquid Calibrators for GHb/A1c Level 1 and Level 2." While it confirms the device is substantially equivalent to a predicate, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information from the given input. The document is solely an FDA clearance letter and does not detail the technical study data or acceptance criteria used for approval.

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