Cleared Traditional

K904116 - IRON 5 X CONC REAGENT

K904116 is the FDA 510(k) clearance for IRON 5 X CONC REAGENT by Trace Scientific , Ltd.. It is a Class 1 Chemistry device (product code JMO) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K904116 · Trace Scientific , Ltd. · Chemistry device
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Sep 1990
Decision
21d
Days
Class 1
Risk

K904116 is an FDA 510(k) clearance for the IRON 5 X CONC REAGENT. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on September 27, 1990 after a review of 21 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 Trace Scientific , Ltd. devices

Submission Details

510(k) Number K904116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date September 27, 1990
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
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 K904116.
SYNERMED UIBC REAGENT KIT
K922784 · Synermed, Inc. · Jul 1992
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
K913922 · Em Diagnostic Systems, Inc. · Sep 1991
BIOTROL UIBC REAGENT
K912795 · Biotrol, USA, Inc. · Aug 1991
IRON REAGENTS PRODUCT CODES 7725 AND 7726
K901960 · American Research Products Co. · May 1990
CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
K883104 · Technicon Instruments Corp. · Oct 1988
UNSATURATED IRON BINDING CAPACITY
K881761 · Data Medical Associates, Inc. · Jul 1988