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510(k) K173683

LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers by DiaSorin, Inc. — Product Code PRI

K173683 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers". The FDA issued a decision of Substantially Equivalent on February 27, 2018. The device falls under product code PRI (Procalcitonin Assay), a Class II device regulated under 21 CFR 866.3215. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2018
Date Received
December 1, 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).

Other clearances by DiaSorin, Inc.

  • K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (June 4, 2026)
  • DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (December 23, 2025)
  • K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (October 27, 2023)
  • K223403 — LIAISON Anti-HAV; LIAISON XS (December 9, 2022)
  • K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (July 26, 2022)
  • K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control Set (July 14, 2022)
  • K193650 — LIAISON Ferritin (September 14, 2021)
  • K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K202574 — LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K210272 — LIAISON Anti-HAV (February 9, 2021)

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)
  • 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