Cleared Traditional

K262597 - Access BNP II

K262597 is an FDA 510(k) clearance for Access BNP II, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code NBC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K262597 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
85d
Days
Class 2
Risk

K262597 is an FDA 510(k) clearance for the Access BNP II. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on October 20, 2026 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1117 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262597

510(k) Number K262597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2026
Decision Date October 20, 2026
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 89d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBC Device Classification - Class 2, Special Controls

Product Code NBC Test, Natriuretic Peptide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1117
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - NBC Test, Natriuretic Peptide

All 46
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K262597.
Access NT-proBNP
K262109 · Beckman Coulter, Inc. · Sep 2026
Access BNP II
K252169 · Beckman Coulter, Inc. · Mar 2026
Alere NT-proBNP for Alinity i
K253539 · Axis-Shield Diagnostics, Ltd. · Feb 2026
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
K262597 · Access BNP II
Download PDF FDA Summary Beckman Coulter, Inc.