Procalcitonin Assay
FDA product code PRI · Class II (moderate risk) · 21 CFR 866.3215 · Microbiology
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).
8510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT)PRI · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/26/2022SE |
| K192815 | Elecsys BRAHMS PCTPRI · Traditional | Roche Diagnostics | 03/09/2020SE |
| K173927 | Elecsys BRAHMS PCTPRI · Traditional | Roche Diagnostics | 07/06/2018SE |
| K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN…PRI · Traditional | DiaSorin, Inc. | 02/27/2018SE |
| K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT…PRI · Traditional | Fujirebio Diagnostics,Inc. | 12/10/2017SE |
| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S…PRI · Traditional | Fisher Diagnostics | 06/01/2017SE |
| K171338 | B R A H M S PCT sensitive KRYPTORPRI · Traditional | Brahms GmbH | 05/31/2017SE |
| K162827 | Vidas B.R.A.H.M.S. PCT (PCT)PRI · Traditional | bioMerieux, Inc. | 02/23/2017SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0428-2022 Class II | VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… | bioMerieux, Inc. | 09/22/2021Open, Classified |