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  • 1.  IVDs that can be run on multiple instruments

    This message was posted by a user wishing to remain anonymous
    Posted 02-May-2023 07:56
    This message was posted by a user wishing to remain anonymous

    For clinical chemistry IVDs that can be run on multiple instruments, Do manufactures need to provide validated applications for each instrument the clinical chemistry IVDs runs on.



  • 2.  RE: IVDs that can be run on multiple instruments

    Posted 03-May-2023 05:59

    Hello Anon,

    The simple answer is yes.  If the IVD assay can be used on different instruments, then the assay needs to be validated on those different instruments.  This is quite common and expected because there can be variations in the instruments, operations, and function.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: IVDs that can be run on multiple instruments

    Posted 03-May-2023 08:03

    This guidance document may be helpful with the requirements:
    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/replacement-reagent-and-instrument-family-policy-in-vitro-diagnostic-devices



    ------------------------------
    Suraj Maharjan
    Sr. Regulatory Affairs Specialist
    Windham NH
    United States
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    Original Message


  • 4.  RE: IVDs that can be run on multiple instruments

    This message was posted by a user wishing to remain anonymous
    Posted 03-May-2023 15:33
    This message was posted by a user wishing to remain anonymous

    Yes as part of the CLIA categorization process the assay needs to be validation on each instrument and then each IVD assay needs to be submitted to the FDA for CLIA categorization on each instrument.


    Original Message


  • 5.  RE: IVDs that can be run on multiple instruments

    This message was posted by a user wishing to remain anonymous
    Posted 04-May-2023 08:53
    This message was posted by a user wishing to remain anonymous

    would this be the case for something like a PCR that can be run across multiple instruments with similar parameters 


    Original Message


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