Hello Anon,
It might be a bit difficult to answer completely without knowing the type of reagents and instruments which are being used. Though fundamentally this is possible to have reagents cleared through 510(k) process agnostic to the instrument which is being used - this would be part of the analytical validation and validation of the device. In this case, you seem to indicate the reagent is already cleared with one instrument - if wanting to use on another instrument this may be done internally with a validation or it may require a new 510(k). It really depends on the initial 510(k) was cleared. Indeed this may fall under the Replacement Reagent guidance published by FDA, but again would need to know how the initial reagents were cleared and the instrument being used. You might want to seek some expert advice to better understand and able to show in more detail the cleared assay.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 20-Apr-2023 16:48
From: Anonymous Member
Subject: FDA IVD Submission: Reagents and differing instruments
This message was posted by a user wishing to remain anonymous
Hi all,
In the US, how would one register the following *IVD* product with FDA most efficiently?
Test system = "Instrument A" Class 1 instrument (exempt from 510(k)) + reagent kits.
The analytes tested by the reagent kits have been cleared or approved on an instrument of a different technology ("Instrument B") but never on Instrument A type instruments before. Note that Instrument A and Instrument B are NOT part of the same family of instruments.
1. Would it be possible to conduct a method comparison between the performance of Instrument A and Instrument B testing the same analyte from the same samples to support a 510(k) (assuming the analyte is subject to 510(k)), even though the instrument types are different?
2. Can Replacement Reagent and Instrument Family Policy be used if Instrument A is exempt from 510(k)?
3. What else should I be considering as I design this registration strategy?
Thank you!