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510(k) Data Aggregation

    K Number
    K993131
    Device Name
    NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
    Manufacturer
    PRIMUS, INC.
    Date Cleared
    2000-05-22

    (245 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMUS, INC.

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

    Measurement of Glycohemoglobin in blood. In vitro diagnostic use only. NycoCard HbA1c is a laboratory test intended for the quantitative determination of percent glycated hemoglobin in whole blood using the system to monitor long term blood glucose control in individuals with diabetes mellitus.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the NycoCard HbA1c Glycated Hemoglobin Assay. It specifies the intended use and regulatory classification but does not contain the acceptance criteria or a study describing the device's performance against those criteria.

    Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based solely on the provided text. The document confirms that the device is "substantially equivalent" to a legally marketed predicate device, which implies that performance data was submitted and found acceptable by the FDA, but the details of that data and the specific acceptance criteria are not included here.

    To answer your request, I would need access to the full 510(k) submission, which typically contains the performance data and the associated acceptance criteria.

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