PRI — Procalcitonin Assay Class II
Classification Details
- Product Code
- PRI
- Device Class
- Class II
- Regulation Number
- 866.3215
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220262 | siemens healthcare diagnostics | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) | August 26, 2022 |
| K192815 | roche diagnostics | Elecsys BRAHMS PCT | March 9, 2020 |
| K173927 | roche diagnostics | Elecsys BRAHMS PCT | July 6, 2018 |
| K173683 | diasorin | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT | February 27, 2018 |
| K172713 | fujirebio diagnostics | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS P | December 10, 2017 |
| K170652 | fisher diagnostics | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R | June 1, 2017 |
| K171338 | brahms | B R A H M S PCT sensitive KRYPTOR | May 31, 2017 |
| K162827 | biomerieux | VIDAS B.R.A.H.M.S. PCT (PCT) | February 23, 2017 |