BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    PMA: P050042 · Decision Jun 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
    Trade Name
    ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
    PMA Number
    P050042
    Device Class
    FDA Class 2
    Product Code
    MZO
    Generic Name
    Assay, enzyme linked immunosorbent, hepatitis c virus
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    June 7, 2006
    Date Received
    November 23, 2005
    Expedited Review
    N
    Docket Number
    06M-0389

    Advisory Committee Statement

    APPROVAL FOR THE ABBOTT ARCHITECT ANTI-HCV. THIS DEVICE IS INDICATED FOR: THE ARCHITECT ANTI-HCV ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN). ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO PROVIDE PRESUMPTIVE EVIDENCE OF INFECTION WITH HCV (STATE OF INFECTION OR ASSOCIATED DISEASE NOT DETERMINED) IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THE ARCHITECT ANTI-HCV CALIBRATOR IS USED FOR THE CALIBRATION OF THE ARCHITECT I SYSTEM WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN). THE ARCHITECT ANTI-HCV CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE ARCHITECT I SYSTEM WITH THE ARCHITECT ANTI-HCV REAGENT KIT. REFER TO THE ARCHITECT ANTI-HCV ASSAY REAGENT PACKAGE INSERT FOR THE FULL LISTING OF INFORMATION REGARDING THE ASSAY. THE ARCHITECT ANTI-HCV CONTROLS ARE USED TO PROVIDE AN ESTIMATION OF TEST PRECISION AND TO DETECT SYSTEMATIC ANALYTICAL DEVIATIONS OF THE ARCHITECT I SYSTEM (REAGENTS, CALIBRATOR, AND INSTRUMENT (WHEN THE SYSTEM IS USED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN). THE ARCHITECT ANTI-HCV CONTROLS HAVE BEEN VALIDATED FOR USE ONLY ON THE ARCHITECT I SYSTEM WITH THE ARCHITECT ANTI-HCV REAGENT KIT.

    Classifications

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

    Product Code Device Name
    MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus