How do think the first device got FDA clearance? It wasn't through a 510k process as a predicate didn't exist. Any too complex to go through here. But you have been deceived by the politics of the issue by mischievous industry malcontents in your short research rather than getting the full understanding of the requirements.Go straight to the FDA website and study their 510k process.
Ann: Lumos Receives US FDA Clearance for FebriDx, page-403
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