Cleared Traditional

K884649 - TOTAL IRON BINDING CAPACITY TEST

K884649 is an FDA 510(k) clearance for TOTAL IRON BINDING CAPACITY TEST, manufactured by Sclavo, Inc.. The device is a Class 1 Chemistry device with product code JQE cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K884649 · Sclavo, Inc. · Chemistry device
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Dec 1988
Decision
37d
Days
Class 1
Risk

K884649 is an FDA 510(k) clearance for the TOTAL IRON BINDING CAPACITY TEST. Classified as Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (product code JQE), Class I - General Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on December 14, 1988 after a review of 37 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 Sclavo, Inc. devices

FDA 510(k) Submission Details - K884649

510(k) Number K884649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1988
Decision Date December 14, 1988
Days to Decision 37 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
51d faster than avg
Panel avg: 88d · This submission: 37d
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 K884649.
CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
K970248 · Canyon Diagnostics, Inc. · Feb 1997
KODAK EKTACHEM DT SLIDES (FE)
K934358 · Eastman Kodak Company · Mar 1994
J&S PEDIATRIC IRON SATURATING REAGENT
K910672 · J.S. Medical Assoc. · Apr 1991
TIBC PRETREATMENT KIT
K842019 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1984