Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

If I have an IVD assay that went thorough the 510k process and got cleared with general instrument. What are the requirements if I need to tie it to a certain instrument? What are all the validation requirements? Does this have to be submitted through the 510(k) again?

Thank you!

Hi Anon

The guidance on general and specific uses may help here.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/generalspecific-intended-use-guidance-industry


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Anne LeBlanc
United States
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Original Message:
Sent: 26-Jan-2023 08:18
From: Anonymous Member
Subject: adding instrument with a cleared IVD

This message was posted by a user wishing to remain anonymous

Hi,

If I have an IVD assay that went thorough the 510k process and got cleared with general instrument. What are the requirements if I need to tie it to a certain instrument? What are all the validation requirements? Does this have to be submitted through the 510(k) again?

Thank you!