Cleared Traditional

K051265 - ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYP...

K051265 is an FDA 510(k) clearance for ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYP..., manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code NBC cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K051265 · Bayer Healthcare, LLC · Chemistry device
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Jun 2005
Decision
28d
Days
Class 2
Risk

K051265 is an FDA 510(k) clearance for the ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY. 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 13, 2005 after a review of 28 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.

View all Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K051265

510(k) Number K051265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2005
Decision Date June 13, 2005
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 40
Devices cleared under the same product code (NBC) and FDA review panel - the closest regulatory comparables to K051265.
TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200
K052789 · Biosite Incorporated · Jan 2006
ELECSYS PROBNP IMMUNOASSAY
K051382 · Roche Diagnostics Corp. · Dec 2005
TRIAGE BNP TEST, MODEL 98000XR
K051787 · Biosite Incorporated · Sep 2005
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
K043228 · Bayer Healthcare, LLC · Apr 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