Cleared Traditional

TIBC (K981279) - FDA 510(k) Clearance

Class I Chemistry device.

K981279 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
42d
Days
Class 1
Risk

K981279 is an FDA 510(k) clearance for the TIBC. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 20, 1998 after a review of 42 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 Abbott Laboratories devices

Submission Details

510(k) Number K981279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1998
Decision Date May 20, 1998
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 17
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K981279.
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
RANDOX IRON
K974604 · Randox Laboratories, Ltd. · Jan 1998
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
K960485 · Beckman Instruments, Inc. · May 1996
OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT
K955139 · Olympus America, Inc. · Feb 1996