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  • 1.  Class 2 Assay development on Class 1 Instrument

    This message was posted by a user wishing to remain anonymous
    Posted 21-Feb-2023 13:07
    This message was posted by a user wishing to remain anonymous

    Hello,

    Instrument A is an IVD which is being developed for an assay. Instrument and assay are developed by two different manufacturers in collaboration. Assay developer wants to hold proprietary information and the 510K. This assay will be run on instrument A. The primary purpose of the instrument A is to run the Class II assay. 

    Instrument A manufacturer wants to have the assay claim as their intended purpose statement. The problem is

    •  Instrument in itself a Class A .
    •  Instrument when run with assay with claims of the assay would be up-classified as class B. Ideal pathway is to get these two cleared together but due to confidentiality issues it's not possible.
    • Assay will have its own 510K

    How can Instrument manufacturer strategize their submission to claim the assay intended use? ( In drug world we can reference the other party's drug master file).

     Is there a provision to cross reference the other party's submission while both the approval processes are run in parallel?

    Thanks!



  • 2.  RE: Class 2 Assay development on Class 1 Instrument

    Posted 22-Feb-2023 02:56

    Hello Anon,

    First there are some terms being inter-mingled which not sure what jurisdiction you are addressing, i.e. Class A and B implying IMDRF/GHTF or European Union and 510(k) for the United States.  Handling an assay and instrument which are managed by two different companies can be managed, though takes some work showing use of the device.  On the instrument side, maybe not so much.  As an example, in a 510(k) submission the Assay would be the main device under review.  All of the analytical and clinical testing performed with the Assay and the Instrument would be provided in the submission.  In this type of scenario, there would be some basic information provided about the instrument and yes possibly reference to a Device Master File (MAF) in the United States if the instrument is considered Class I.  In the European Union this could be a little more complicated as the Notified Body review of the Assay may also want to see detailed information related to the Instrument.  We have done these type of submissions before, so it is possible, they just need to be organised well clearly describing the Assay, the Instrument, and how they are used together.  In most cases, the analytical and clinical testing sort-of "qualifies" the instrument at the same time, but again needs to be presented correctly.



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


  • 3.  RE: Class 2 Assay development on Class 1 Instrument

    This message was posted by a user wishing to remain anonymous
    Posted 23-Feb-2023 08:46
    This message was posted by a user wishing to remain anonymous

    Thank you both.

    My apologies for the typo. It's Class 1 and 2 and I am talking about the FDA world. I found the link Master Files | FDA .

    My understanding is that we can reference MAFs for certain sections within the 510K.

    In this case, we can have the same intended use as the assay and can file for a 510K for the instrument by cross-referencing the sections using MAF. (I mean both the instrument manufacturer and assay developer can own their respective 510Ks by cross referencing MAFs)

    Can anyone of you share your real-world experience?   

    Thanks Again!


    Original Message


  • 4.  RE: Class 2 Assay development on Class 1 Instrument

    This message was posted by a user wishing to remain anonymous
    Posted 22-Feb-2023 09:12
    This message was posted by a user wishing to remain anonymous

    I assume you are referring to US FDA since you mentioned 510(k) and Class II. But you also mentioned Class A and Class B which this could be the EU or another region.

    For US FDA, if the assay manufacturer was not submitting a 510(k) for the assay and they were willing to submit a device master file containing confidential information to the FDA for authorization, then the instrument manufacturer could reference the assay manufacturer's authorized master file in their submission. But since you mentioned the assay manufacturer will submit a 510(k), then the assay manufacturer would not be able to submit a master file, since master files are only accepted by the FDA for organizations that will not directly submit the information in a pre-market submission.


    Original Message


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