Cleared Traditional

K830032 - TOTAL IRON BINDING CAPACITY TEST

K830032 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 JQF cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K830032 · Sclavo, Inc. · Chemistry device
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Jan 1983
Decision
21d
Days
Class 1
Risk

K830032 is an FDA 510(k) clearance for the TOTAL IRON BINDING CAPACITY TEST. Classified as Bathophenanthroline, Iron Binding Capacity (product code JQF), Class I - General Controls.

Submitted by Sclavo, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983 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 Sclavo, Inc. devices

FDA 510(k) Submission Details - K830032

510(k) Number K830032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1983
Decision Date January 28, 1983
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.

JQF Device Classification - Class 1, General Controls

Product Code JQF Bathophenanthroline, 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 - JQF Bathophenanthroline, Iron Binding Capacity

Devices cleared under the same product code (JQF) and FDA review panel - the closest regulatory comparables to K830032.
WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR
K984122 · Wako Chemicals USA, Inc. · Jan 1999
WAKO(TM) UIBC
K875176 · Wako Chemicals USA, Inc. · Feb 1988
TRANSFERMETER
K863066 · J. D. Assoc. · Dec 1986
IRON & TICB
K810086 · Bio-Analytics Laboratories, Inc. · Jan 1981
ELVI TOTAL IRON BINDING CAPACITY
K792409 · Volu Sol Medical Industries · Dec 1979