Cleared Traditional

DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE (K946354) - FDA 510(k) Clearance

Class I Chemistry device.

K946354 · Data Medical Associates, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
129d
Days
Class 1
Risk

K946354 is an FDA 510(k) clearance for the DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on May 8, 1995 after a review of 129 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Data Medical Associates, Inc. devices

Submission Details

510(k) Number K946354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1994
Decision Date May 08, 1995
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 88d · This submission: 129d
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 45
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K946354.
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115 · Dade Behring, Inc. · Jan 2000
UIBC
K982041 · Abbott Laboratories · Jul 1998
TIBC
K981654 · Abbott Laboratories · Jul 1998
TIBC
K981279 · Abbott Laboratories · May 1998
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
K960485 · Beckman Instruments, Inc. · May 1996
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
K931493 · Eastman Kodak Company · May 1993