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510(k) K173927

Elecsys BRAHMS PCT by Roche Diagnostics — Product Code PRI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2018
Date Received
December 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Procalcitonin Assay
Device Class
Class II
Regulation Number
866.3215
Review Panel
MI
Submission Type

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).

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  • K241453 — Elecsys sFlt-1 and Elecsys PlGF (February 7, 2025)
  • K233060 — Elecsys Folate III (June 17, 2024)
  • K220272 — cobas pulse blood glucose monitoring system (April 26, 2024)

Other clearances for product code PRI

  • K220262 — Dimension EXL LOCI BRAHMS Procalcitonin (PCT) (August 26, 2022)
  • K192815 — Elecsys BRAHMS PCT (March 9, 2020)
  • K173683 — LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT (February 27, 2018)
  • K172713 — Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S P (December 10, 2017)
  • K170652 — ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R (June 1, 2017)
  • K171338 — B R A H M S PCT sensitive KRYPTOR (May 31, 2017)
  • K162827 — VIDAS B.R.A.H.M.S. PCT (PCT) (February 23, 2017)