Cleared Traditional

K232164 - Access NT-proBNP (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232164 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
266d
Days
Class 2
Risk

K232164 is an FDA 510(k) clearance for the Access NT-proBNP. 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 April 12, 2024 after a review of 266 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K232164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2023
Decision Date April 12, 2024
Days to Decision 266 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
178d slower than avg
Panel avg: 88d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 44
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K232164.
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
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