BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Enzyme Immunoassay, Tracrolimus

    PMA: P970007 · Supplement: S002 · Decision Mar 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Enzyme Immunoassay, Tracrolimus
    Trade Name
    IMX TACROLIMUS II
    PMA Number
    P970007
    Supplement Number
    S002
    Device Class
    FDA Class 2
    Product Code
    MLM
    Generic Name
    ENZYME IMMUNOASSAY, TRACROLIMUS
    Regulation Number
    862.1678
    Medical Specialty
    Clinical Chemistry
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 30, 2001
    Date Received
    February 27, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE CURRENT LABELING FOR THE DEVICE PER 21 CFR 814.39(D)(2). THE CURRENT PACKAGE INSERT STATES "HEMATOCRIT VALUES RANGING FROM 25 TO 45% RESULTED IN LESS THAN 12% ERROR IN DETECTING TACROLIMUS." THE PACKAGE INSERT WILL BE MODIFIED TO STATE "HEMATOCRIT INTERFERENCE WAS EVALUATED BY SPIKING KNOWN AMOUNTS OF TACROLIMUS INTO POOLED, WHOLD BLOOD SAMPLES DILUTED WITH SALINE. HEMATOCRIT VALUES RANGING FROM 25 TO 45% RESULTED IN LESS THAN 31% ERROR IN DETECTING TACROLIMUS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MLM Enzyme Immunoassay, Tracrolimus