Cleared Traditional

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS (K043228) - FDA 510(k) Clearance

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

K043228 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
151d
Days
Class 2
Risk

K043228 is an FDA 510(k) clearance for the ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS. Classified as Test, Natriuretic Peptide (product code NBC), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on April 22, 2005 after a review of 151 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 Bayer Healthcare, LLC devices

Submission Details

510(k) Number K043228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2004
Decision Date April 22, 2005
Days to Decision 151 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 88d · This submission: 151d
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 25
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K043228.
DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR
K061795 · Dade Behring, Inc. · Sep 2006
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158
K060632 · Ortho-Clinical Diagnostics, Inc. · Jun 2006
ELECSYS PROBNP IMMUNOASSAY
K051382 · Roche Diagnostics Corp. · Dec 2005
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT
K043476 · Dade Behring, Inc. · Feb 2005
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
K042347 · Dade Behring, Inc. · Nov 2004
DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423
K041417 · Dade Behring, Inc. · Jul 2004