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510(k) K192815

Elecsys BRAHMS PCT by Roche Diagnostics — Product Code PRI

K192815 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys BRAHMS PCT". The FDA issued a decision of Substantially Equivalent on March 9, 2020. The device falls under product code PRI (Procalcitonin Assay), a Class II device regulated under 21 CFR 866.3215. Roche Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2020
Date Received
October 1, 2019
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).

Other clearances by Roche Diagnostics

  • K252323 — cobas pulse blood glucose monitoring system (June 12, 2026)
  • K252431 — Elecsys Calcitonin (April 24, 2026)
  • K252280 — Elecsys Anti-SARS-CoV-2 S (April 13, 2026)
  • K260048 — Elecsys Anti-HAV IgM (April 7, 2026)
  • K260046 — Elecsys Anti-HBc II (April 7, 2026)
  • K260049 — Elecsys Anti-HBc IgM (April 7, 2026)
  • K260026 — Tina-quant Cardiac high sensitivity CRP III (April 2, 2026)
  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (February 12, 2026)
  • K253839 — Elecsys Anti-SARS-CoV-2 (December 17, 2025)

Other clearances for product code PRI

  • K220262 — Dimension EXL LOCI BRAHMS Procalcitonin (PCT) (August 26, 2022)
  • K173927 — Elecsys BRAHMS PCT (July 6, 2018)
  • 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)

FDA data resources