Cleared Traditional

K864548 - ALFERR TIBC TUBE

K864548 is an FDA 510(k) clearance for ALFERR TIBC TUBE, manufactured by Benchmark Reagents. The device is a Class 1 Chemistry device with product code JQE cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K864548 · Benchmark Reagents · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
75d
Days
Class 1
Risk

K864548 is an FDA 510(k) clearance for the ALFERR TIBC TUBE. Classified as Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (product code JQE), Class I - General Controls.

Submitted by Benchmark Reagents (Australia, AU). The FDA issued a Cleared decision on February 2, 1987 after a review of 75 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 Benchmark Reagents devices

FDA 510(k) Submission Details - K864548

510(k) Number K864548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date February 02, 1987
Days to Decision 75 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 88d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

JQE Device Classification - Class 1, General Controls

Product Code JQE Resin, Ion-exchange, Ascorbic Acid, Colorimetry, 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 - JQE Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity

Devices cleared under the same product code (JQE) and FDA review panel - the closest regulatory comparables to K864548.
KODAK EKTACHEM DT SLIDES (FE)
K934358 · Eastman Kodak Company · Mar 1994
J&S PEDIATRIC IRON SATURATING REAGENT
K910672 · J.S. Medical Assoc. · Apr 1991
TOTAL IRON BINDING CAPACITY TEST
K884649 · Sclavo, Inc. · Dec 1988
TIBC PRETREATMENT KIT
K842019 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1984