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510(k) K162827

VIDAS B.R.A.H.M.S. PCT (PCT) by bioMerieux, Inc. — Product Code PRI

K162827 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "VIDAS B.R.A.H.M.S. PCT (PCT)". The FDA issued a decision of Substantially Equivalent on February 23, 2017. The device falls under product code PRI (Procalcitonin Assay), a Class II device regulated under 21 CFR 866.3215. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2017
Date Received
October 7, 2016
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 bioMerieux, Inc.

  • K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (July 8, 2026)
  • K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (April 15, 2026)
  • K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (March 26, 2026)
  • K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (August 21, 2025)
  • K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (April 30, 2025)
  • K234012 — VITEK COMPACT PRO (March 14, 2025)
  • K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (June 12, 2024)
  • K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (June 7, 2024)
  • K240279 — VIDAS TBI (GFAP, UCH-L1) (May 1, 2024)
  • K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)

Other clearances for product code PRI

  • K220262 — Dimension EXL LOCI BRAHMS Procalcitonin (PCT) (August 26, 2022)
  • K192815 — Elecsys BRAHMS PCT (March 9, 2020)
  • 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)

FDA data resources