Cleared Traditional

K131975 - ACE DIRECT TOTAL IRON-BINDING CAPACITY ...

K131975 is the FDA 510(k) clearance for ACE DIRECT TOTAL IRON-BINDING CAPACITY ... by Alfa Wassermann Diagnostic Technologies, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K131975 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry device
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Oct 2013
Decision
96d
Days
Class 2
Risk

K131975 is an FDA 510(k) clearance for the ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT.... Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on October 2, 2013 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1440 - 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 K131975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2013
Decision Date October 02, 2013
Days to Decision 96 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
8d slower than avg
Panel avg: 88d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

All 83
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K131975.
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
K974859 · Diagnostic Chemicals , Ltd. · Jan 1998
LIQUID LDH-L REAGENT SET
K973589 · Pointe Scientific, Inc., · Oct 1997
LACTATE DEHYDROGENASE (LD)
K970684 · Randox Laboratories, Ltd. · May 1997
LACTATE DEHYDROGENASE REAGENT SET
K961431 · Pointe Scientific, Inc., · Jun 1996
LACTATE DEHYDROGENASE REAGENT SYSTEM
K952747 · Medical Diagnostic Technologies, Inc. · Aug 1995
HICHEM LDH/L REAGENT KIT
K946022 · Hichem Diagnostics · Feb 1995