Cleared Traditional

K113253 - ACE AXCEL CLINICAL CHEMISTRY SYSTEM

K113253 is the FDA 510(k) clearance for ACE AXCEL CLINICAL CHEMISTRY SYSTEM by Alfa Wassermann Diagnostic Technologies, Inc.. It is a Class 1 Chemistry device (product code JJE) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K113253 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
197d
Days
Class 1
Risk

K113253 is an FDA 510(k) clearance for the ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REA.... Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on May 17, 2012 after a review of 197 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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 K113253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2011
Decision Date May 17, 2012
Days to Decision 197 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
109d slower than avg
Panel avg: 88d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 141
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K113253.
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
K183375 · Horiba, Ltd. · Feb 2019
RX DAYTONA PLUS CHEMISTRY ANALYZER
K131554 · Randox Laboratories, Ltd. · Jan 2014
DIMENSION EXL WITH LM SYSTEM
K130276 · Siemens Healthcare Diagnostics, Inc. · Mar 2013
DIMENSION CLINICAL CHEMISTRY SYSTEM
K112999 · Siemens Healthcare Diagnostics · Nov 2011
TC MATRIX CLINICAL CHEMISTRY ANALYZER
K073370 · Teco Diagnostics · May 2008
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
K063144 · Ortho-Clinical Diagnostics, Inc. · Nov 2006