FebriDx Bacterial/Non-bacterial Assay

FebriDx is a rapid lateral flow immunoassay that detects two host response proteins—Myxovirus resistance protein A (MxA) and C-reactive protein (CRP)—from fingerstick blood to aid in diagnosing bacterial versus non-bacterial acute respiratory infections. It is a single-use, disposable device indicated for patients aged 12-64 with respiratory infection symptoms lasting less than 7 days and fever onset within 3 days, producing a visual qualitative result.

The device is substantially identical to the predicate (K230917): same lateral flow immunochromatographic assay format, same measurands (MxA/CRP), same all-in-one cassette design with integrated safety lancet and buffer delivery, same sample type (fingerstick blood), same qualitative measurement, same 10-minute to 1-hour read window, and same external positive/negative controls. The primary difference is removal of the phrase 'who present to urgent care or emergency care settings' from the intended use statement.

ISO 10993-1 (biological evaluation), ISO 15223-1 (device symbols and labeling), CLSI EP07 (interference testing), CLSI EP12-A2 (qualitative test performance), CLSI EP17-A2 (detection capability), CLSI EP18-A2 (risk management for laboratory errors), and CLSI EP25-A (reagent stability).