Cleared Traditional

Alere NT-proBNP for Alinity i

K253539 · Axis-Shield Diagnostics, Ltd. · Chemistry
Feb 2026
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K253539 is an FDA 510(k) clearance for the Alere NT-proBNP for Alinity i, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on February 18, 2026, 97 days after receiving the submission on November 13, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.

Submission Details

510(k) Number K253539 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2025
Decision Date February 18, 2026
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code NBC — Test, Natriuretic Peptide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1117

Similar Devices — NBC Test, Natriuretic Peptide

All 43
Alere NT-proBNP for Alinity i Reagent Kit
K241176 · Axis-Shield Diagnostics, Ltd. · Jan 2025
Access NT-proBNP
K232164 · Beckman Coulter, Inc. · Apr 2024
ADVIA Centaur? NT-proBNPII (PBNPII)
K220265 · Siemens Healthcare Diagnostics, Inc. · Sep 2023
Elecsys proBNP II, Elecsys proBNP II STAT
K223637 · Roche Diagnostics · Jul 2023
Elecsys proBNP II, Elecsys proBNP II STAT
K210546 · Roche Diagnostics · Mar 2022
ST AIA-PACK BNP Assay
K211199 · Tosoh Bioscience, Inc. · Nov 2021