Cleared Traditional

K012337 - BAYER ADVIA IMS SYSTEM

Also marketed or referenced as:
C-REACTIVE PROTEIN SYSTEM

K012337 is an FDA 510(k) clearance for BAYER ADVIA IMS SYSTEM, manufactured by Bayer Corp.. The device is a Class 2 Chemistry device with product code DCN cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K012337 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
135d
Days
Class 2
Risk

K012337 is an FDA 510(k) clearance for the BAYER ADVIA IMS SYSTEM. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on December 6, 2001 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - 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 Corp. devices

FDA 510(k) Submission Details - K012337

510(k) Number K012337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2001
Decision Date December 06, 2001
Days to Decision 135 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
47d slower than avg
Panel avg: 88d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCN Device Classification - Class 2, Special Controls

Product Code DCN System, Test, C-reactive Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 - DCN System, Test, C-reactive Protein

All 40
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K012337.
TINA-QUANT CRP (LATEX)
K032336 · Roche Diagnostics Corp. · Aug 2003
C-REACTIVE PROTEIN (CRP)
K030899 · Abbott Laboratories · Jul 2003
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · Beckman Coulter, Inc. · Jul 2002
CRP HS TEST SYSTEM
K003400 · Roche Diagnostics Corp. · May 2001
RCRP FLEX REAGENT CARTRIDGE
K003419 · Dade Behring, Inc. · Feb 2001
WAKO CRP-UL, CRP-UL CALIBRATOR SET
K003342 · Wako Chemicals USA, Inc. · Jan 2001