Cleared Traditional

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS (K040425) - FDA 510(k) Clearance

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

K040425 · Bayer Healthcare, LLC · Chemistry device
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Jun 2004
Decision
117d
Days
Class 2
Risk

K040425 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 June 14, 2004 after a review of 117 days - within the typical 510(k) review window.

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 K040425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2004
Decision Date June 14, 2004
Days to Decision 117 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
29d slower than avg
Panel avg: 88d · This submission: 117d
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 K040425.
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
ELECSYS PROBNP IMMUNOASSAY
K032646 · Roche Diagnostics Corp. · Nov 2003
ELECSYS PROBNP IMMUNOASSAY
K022516 · Roche Diagnostics Corp. · Nov 2002