PRI
8 FDA 510(k) clearances · Product code
139 daysmedian time to decision
207 days90th percentile
8clearances measured
FDA profile
- Official device name
- Procalcitonin Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3215
- Medical specialty
- Microbiology
- FDA 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).
- Adverse events (MAUDE)
- 2021: 157 · 2022: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Dimension EXL LOCI BRAHMS Procalcitonin (PCT) (K220262) | Siemens Healthcare Diagnostics, Inc. | 2022-08-26 |
| Elecsys BRAHMS PCT (K192815) | Roche Diagnostics | 2020-03-09 |
| Elecsys BRAHMS PCT (K173927) | Roche Diagnostics | 2018-07-06 |
| LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers (K173683) | DiaSorin, Inc. | 2018-02-27 |
| Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set (K172713) | Fujirebio Diagnostics,Inc. | 2017-12-10 |
| ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls (K170652) | Fisher Diagnostics | 2017-06-01 |
| B R A H M S PCT sensitive KRYPTOR (K171338) | Brahms GmbH | 2017-05-31 |
| VIDAS B.R.A.H.M.S. PCT (PCT) (K162827) | bioMerieux, Inc. | 2017-02-23 |
Track PRI automatically
Every clearance here is in the API, with alerts when new ones post.