BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    PMA: P000010 · Supplement: S007 · Decision Jun 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
    Trade Name
    AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0
    PMA Number
    P000010
    Supplement Number
    S007
    Device Class
    FDA Class 2
    Product Code
    MZP
    Generic Name
    Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
    Regulation Number
    866.3170
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 22, 2006
    Date Received
    January 31, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE EXTENSION OF THE SHELF LIFE TO 24 MONTHS OF THE HCV MASTER MIX, VERSION 2,.0, A COMPONENT OF THE AMPLICOR HCV TEST, V2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AMPLICOR HCV TEST, V2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION OF HCV RNA INHUMAN SERUM OR PLASMA FROM BLOOD COLLECTED IN EDTA (EDTA PLASMA). THE TEST DETECTS BY REVERSE TRANSCRIBING TARGET HCV RNA IN COMPLIMENTARY DNA (CDNA), AMPLIFYING CDNA BY POLYMERASE CHAIN REACTION (PCR), HYBRIDIZING AMPLIFIED CDNA WITH AN OLIGONUCLEOTIDE PROBE THAT BINDS ENZYME, AND CATALYZING CONVERSION OF SUBSTRATE TO A COLORED PRODUCT THAT IS RECOGNIZED BY A MICROWELL PLATE READER. THE AMPLICOR HCV TEST, V2.0 IS INDICATED FOR PATIENTS WHO HAVE EVIDENCE OF LIVER DISEASE AND ANTIBODY EVIDENCE OF HCV INFECTION, AND WHO ARE SUSPECTED TO BE ACTIVELY INFECTED WITH HCV. DETECTION OF HCV RNA INDICATES THAT THE VIRUS IS REPLICATING AND THEREFORE IS EVIDENCE OF ACTIVE HCV INFECTION.

    Classifications

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

    Product Code Device Name
    MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus