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 Roche Diagnostics, bioMerieux, Inc. and DiaSorin, 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
Cleared Mar 09, 2020
Elecsys BRAHMS PCT
K192815
Roche Diagnostics
Microbiology · 160d
Cleared Jul 06, 2018
Elecsys BRAHMS PCT
K173927
Roche Diagnostics
Microbiology · 192d
Cleared Feb 27, 2018
LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
K173683
DiaSorin, Inc.
Microbiology · 88d
Cleared Feb 23, 2017
VIDAS B.R.A.H.M.S. PCT (PCT)
K162827
bioMerieux, Inc.
Microbiology · 139d

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.