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510(k) K220262

Dimension EXL LOCI BRAHMS Procalcitonin (PCT) by Siemens Healthcare Diagnostics, Inc. — Product Code PRI

K220262 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "Dimension EXL LOCI BRAHMS Procalcitonin (PCT)". The FDA issued a decision of Substantially Equivalent on August 26, 2022. The device falls under product code PRI (Procalcitonin Assay), a Class II device regulated under 21 CFR 866.3215. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2022
Date Received
January 31, 2022
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 Siemens Healthcare Diagnostics, Inc.

  • K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) (February 27, 2026)
  • K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII) (February 6, 2026)
  • K251630 — Atellica IM Total PSA II (tPSAII) (January 5, 2026)
  • K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII) (December 4, 2025)
  • K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II (October 17, 2025)
  • K242981 — Atellica IM Thyroglobulin (Tg) (June 20, 2025)
  • K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimens (April 25, 2025)
  • K242685 — Atellica® CH Creatinine_3 (Crea3) (December 4, 2024)
  • K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (July 26, 2024)
  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)

Other clearances for product code PRI

  • 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)
  • K162827 — VIDAS B.R.A.H.M.S. PCT (PCT) (February 23, 2017)

FDA data resources