Cleared Traditional

K012340 - BAYER ADVIA SYSTEM

Also marketed or referenced as:
UNSATURATED IRON BINDING CAPACITY (UIBC)

K012340 is the FDA 510(k) clearance for BAYER ADVIA SYSTEM by Bayer Corp.. It is a Class 1 Chemistry device (product code JMO) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K012340 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
69d
Days
Class 1
Risk

K012340 is an FDA 510(k) clearance for the BAYER ADVIA SYSTEM. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 1, 2001 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1415 - 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 Corp. devices

Submission Details

510(k) Number K012340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2001
Decision Date October 01, 2001
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JMO Ferrozine (colorimetric) Iron Binding Capacity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1415
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JMO Ferrozine (colorimetric) Iron Binding Capacity

All 33
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K012340.
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541
K061464 · Ortho-Clinical Diagnostics, Inc. · Jun 2006
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
K052867 · Ortho-Clinical Diagnostics, Inc. · Dec 2005
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
K041793 · Olympus America, Inc. · Jul 2004
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115 · Dade Behring, Inc. · Jan 2000
UIBC
K982041 · Abbott Laboratories · Jul 1998
TIBC
K981654 · Abbott Laboratories · Jul 1998