PRI

Procalcitonin Assay

Product code

PRI

Device name

Procalcitonin Assay

Device class

Class 2

21 CFR

21 CFR 866.3215

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

8 (all years; only the last 3 years are listed here)

FDA classification definition

To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).

Definition text from the FDA device classification database (U.S. federal government work, public domain).