Hello Yunyuan,
Making a 510(k) submission for reagents which use another instrument can be done, just is a bit more complicated. If the instrument is already cleared, than this can be referenced in the submission with the 510(k) number and of course include any applicable information, i.e. analytical testing with the instrument, preparation, etc. Items such as electrical safety testing and software information with the instrument would not necessarily be required. To answer your question, software may be applicable, because it depends if the PCR instrument is doing any analysis specific to the reagent or if there is separate software used. Cybersecurity would probably only be applicable if the analysis for the reagent was a separate software application. You may not need to include some of the software information for the instrument if there is already a cleared 510(k), however, it depends on the interaction with the reagent. If the analysis is specific to the reagent, then the analytical and/or clinical testing could be run on the instrument itself providing the results and the software performance can be referenced back to the instrument 510(k).
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Oct-2023 14:43
From: Yunyuan Wang
Subject: 510k application for a new IVD assay that uses a 510k cleared instrument from another manufacturer
Hello everyone,
I am helping my client submit a 510k application for a PCR reagent kit that they developed. The assay can be run/analyzed on a PCR instrument that was developed by another manufacturer and was previously 510k cleared. The applications that I have done before for the IVD test usually have the test reagent and the the analytical instrument from the same manufacturer. I have seen some 510k applications using a previously cleared instrument as well.
My question is how to proceed with the "Software" and "Cybersecurity" sections in the 510k application. I assume the applicant still needs to perform software V&V with their new assay. Regarding the technical documents related to the software design (SRS, SDS, architecture, cybersecurity etc..) , how can they be included if the applicant doesn't have the access?
I went through some FDA guidance and find this might be relevant. However, a combination of the not cleared assay with the cleared instrument (B+C) seems to be outside of the scope. Replacement Reagent and Instrument Family Policy for IVDs
Is anyone who had the similar experience willing share? Any feedback will be greatly appreciated.
Thank you.
Vivian
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Yunyuan Vivian Wang
Consultant
United States
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