Home / 510(k) Clearances / K241176

510(k) K241176

Alere NT-proBNP for Alinity i Reagent Kit by Axis-Shield Diagnostics, Ltd. — Product Code NBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2025
Date Received
April 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Natriuretic Peptide
Device Class
Class II
Regulation Number
862.1117
Review Panel
CH
Submission Type

Other clearances by Axis-Shield Diagnostics, Ltd.

  • K253539 — Alere NT-proBNP for Alinity i (February 18, 2026)
  • K233541 — ARCHITECT Active-B12 (Holotranscobalamin) (July 31, 2024)
  • K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (October 27, 2017)
  • K121946 — AXIS-SHIELD ACVTIVE-B12 (March 22, 2013)
  • K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C (December 12, 2012)
  • K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (May 7, 2012)
  • K112443 — ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) (December 19, 2011)
  • K110296 — AXIS-SHIELD ANTI-CCP (August 18, 2011)
  • K083868 — ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P (September 25, 2009)
  • K083222 — AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (July 31, 2009)

Other clearances for product code NBC

  • K253539 — Alere NT-proBNP for Alinity i (February 18, 2026)
  • K232164 — Access NT-proBNP (April 12, 2024)
  • K220265 — ADVIA Centaur® NT-proBNPII (PBNPII) (September 24, 2023)
  • K223637 — Elecsys proBNP II, Elecsys proBNP II STAT (July 21, 2023)
  • K210546 — Elecsys proBNP II, Elecsys proBNP II STAT (March 31, 2022)
  • K211199 — ST AIA-PACK BNP Assay (November 8, 2021)
  • K201312 — VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack (October 4, 2021)
  • K192380 — ST AIA-PACK BNP (August 24, 2020)
  • K092649 — ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109 (February 4, 2010)
  • K082645 — DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT CARTRI (September 22, 2008)