Cleared Traditional

K113438 - ACE DIRECT TOTALIRON-BINDING CAPACITY (...

K113438 is the FDA 510(k) clearance for ACE DIRECT TOTALIRON-BINDING CAPACITY (... by Alfa Wassermann Diagnostic Technologies, Inc.. It is a Class 1 Chemistry device (product code JMO) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K113438 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
193d
Days
Class 1
Risk

K113438 is an FDA 510(k) clearance for the ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT,.... Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on June 1, 2012 after a review of 193 days - an extended review 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: 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 Alfa Wassermann Diagnostic Technologies, Inc. devices

Submission Details

510(k) Number K113438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date June 01, 2012
Days to Decision 193 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
105d slower than avg
Panel avg: 88d · This submission: 193d
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 34
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K113438.
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541
K061464 · Ortho-Clinical Diagnostics, Inc. · Jun 2006
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
K052867 · Ortho-Clinical Diagnostics, Inc. · Dec 2005
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
K041793 · Olympus America, Inc. · Jul 2004
BAYER ADVIA SYSTEM
K012340 · Bayer Corp. · Oct 2001
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115 · Dade Behring, Inc. · Jan 2000
UIBC
K982041 · Abbott Laboratories · Jul 1998