PRI · Class II · 21 CFR 866.3215

FDA Product Code PRI: Procalcitonin Assay

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).

Leading manufacturers include Siemens Healthcare Diagnostics, Inc..

8
Total
8
Cleared
124d
Avg days
2017
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Procalcitonin Assay Devices (Product Code PRI)

8 devices
1–8 of 8
Cleared Aug 26, 2022
Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
K220262
Siemens Healthcare Diagnostics, Inc.
Microbiology · 207d

About Product Code PRI - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code PRI since 2017, with 8 receiving FDA clearance (average review time: 124 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

PRI devices are reviewed by the Microbiology panel. Browse all Microbiology devices →