Alere NT-proBNP for Alinity i— 510(k) K253539

Name: FDA 510(k) clearance K253539
Creator: U.S. Food and Drug Administration
Published: 2026-02-18

Substantially Equivalent

Axis-Shield Diagnostics, Ltd.

FDA 510(k) clearance K253539 for Alere NT-proBNP for Alinity i, Substantially Equivalent on 2026-02-18. Applicant: Axis-Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Axis-Shield Diagnostics, Ltd.
Product code: Code NBC
Device class: Class 2
Regulation: 21 CFR 862.1117
Advisory panel: Clinical Chemistry
Date received: 2025-11-13
Decision date: 2026-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code NBC

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K252169 — Access BNP II2026-03-24
K241176 — Alere NT-proBNP for Alinity i Reagent Kit2025-01-16
K232164 — Access NT-proBNP2024-04-12
K220265 — ADVIA Centaur® NT-proBNPII (PBNPII)2023-09-24
K223637 — Elecsys proBNP II, Elecsys proBNP II STAT2023-07-21

More clearances from Axis-Shield Diagnostics, Ltd.

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K233541 — ARCHITECT Active-B12 (Holotranscobalamin)2024-07-31
K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay2017-10-27
K121946 — AXIS-SHIELD ACVTIVE-B122013-03-22
K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C2012-12-12
K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON2012-05-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.