General Discussion-LDX, page-6

Would suggest a read up on 510k application process as part of ones research.

Nevertheless, the predicate device that FebriDx shows substantive equivalence to is the 'Synovasure Alpha Defensin Lateral Flow Test Kit', which is used for the diagnosis of Periprosthetic Joint Infection. Premised on point of care diagnostic, but very different and niche use case.

Further details on comparison can be found here under section V - note that beyond FDA application purposes, I'd say Synovasure bears no relevance to FebriDx.

AIMHO. DYOR.
GLTAH.