Cleared Traditional

AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241 (K863426) - FDA 510(k) Clearance

Class I Chemistry device.

K863426 · American Research Products Co. · Chemistry device
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Sep 1986
Decision
12d
Days
Class 1
Risk

K863426 is an FDA 510(k) clearance for the AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on September 16, 1986 after a review of 12 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 American Research Products Co. devices

Submission Details

510(k) Number K863426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1986
Decision Date September 16, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
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 11
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K863426.
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
K913922 · Em Diagnostic Systems, Inc. · Sep 1991
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
TDX REA IRON/TIBC
K851930 · Abbott Laboratories · May 1985
SYSTE MATE TIBC HEM NO. 67225
K850128 · Em Diagnostic Systems, Inc. · Feb 1985