Curetis Goes After Additional FDA Clearance for LRT Infection Panel

German diagnostics developer Curetis is seeking another 510(k) approval for its Unyvero lower respiration tract (LRT) cartridge so that it can be used to diagnose lower respiratory tract infections like pneumonia using samples from the lung.

The company’s 510(k) application looks to clear the device for use with bronchoalveolar lavage (BAL) specimens, which are obtained from a patient’s lung using a bronchoscope.

The company said its LRT BAL panel covers 50 diagnostic targets with 30 assays and delivers microorganism and resistance marker results in approximately five hours.