Cleared Traditional

TDX REA IRON/TIBC (K851930) - FDA 510(k) Clearance

Class I Chemistry device.

K851930 · Abbott Laboratories · Chemistry device
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May 1985
Decision
22d
Days
Class 1
Risk

K851930 is an FDA 510(k) clearance for the TDX REA IRON/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 24, 1985 after a review of 22 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 K851930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1985
Decision Date May 24, 1985
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
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 18
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K851930.
CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
K883104 · Technicon Instruments Corp. · Oct 1988
TOTAL IRON BINDING CAPACITY (TIBC)
K880546 · Boehringer Mannheim Corp. · Mar 1988
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
K871414 · Em Diagnostic Systems, Inc. · Apr 1987
SYSTE MATE TIBC HEM NO. 67225
K850128 · Em Diagnostic Systems, Inc. · Feb 1985
IRON BINDING CAPACITY CHEMISTRY
K780094 · Harleco · Feb 1978
IRON SET, ITEM NO. 65008
K771927 · Harleco · Nov 1977