Cleared Traditional

K946354 - DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE

K946354 is an FDA 510(k) clearance for DMA UNSATURATED IRON BINDING CAPACITY P..., manufactured by Data Medical Associates, Inc.. The device is a Class 1 Chemistry device with product code JMO cleared through the Traditional 510(k) pathway after a 129-day FDA review.

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

FDA 510(k) Submission Details - K946354

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 88d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

JMO Device Classification - Class 1, General Controls

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.
UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY
K963116 · Diagnostic Chemicals , Ltd. · Aug 1996
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
K960485 · Beckman Instruments, Inc. · May 1996
OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT
K955139 · Olympus America, Inc. · Feb 1996
IRON/UIBC REAGENT
K932517 · Sigma Diagnostics, Inc. · Nov 1993
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT
K933329 · King Diagnostics, Inc. · Oct 1993
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
K931493 · Eastman Kodak Company · May 1993