Clinical chemistry-specific protein IVDs

Intended purpose

A qualitative IVD intended as an adjunct for the detection of joint infection in synovial fluid of patients experiencing pain/inflammation in a replacement joint. Intended to provide positive/negative result for the presence of alpha-defensin in synovial fluid. Not intended to identify a specific type of infection, establish origin or severity of infection. For clinical use by healthcare professionals; not for point-of-care/near-patient use, self-use, self-test, or home use.