Product code PRI— Microbiology
Elecsys BRAHMS PCT
- Classification name
- Procalcitonin Assay
- Device class
- Class 2
- Regulation
- 21 CFR 866.3215
- Advisory panel
- Microbiology
- Total cleared
- 8
- First cleared
- Most recent
FDA classification 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).”
Market context for product code PRI
FDA has cleared devices under product code PRI between 2017 and 2022, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2022
- 2020
- 2018
- 2017
Top applicants under product code PRI
Recent clearances under product code PRI
- K220262 — Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
- K192815 — Elecsys BRAHMS PCT
- K173927 — Elecsys BRAHMS PCT
- K173683 — LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
- K172713 — Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set
- 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 PCT Controls
- K171338 — B R A H M S PCT sensitive KRYPTOR
- K162827 — VIDAS B.R.A.H.M.S. PCT (PCT)
Data sourced from openFDA. This site is unofficial and independent of the FDA.