Cleared Traditional

K113435 - ACE CARBON DIOXIDE(CO2-LC) REAGENT

K113435 is the FDA 510(k) clearance for ACE CARBON DIOXIDE(CO2-LC) REAGENT by Alfa Wassermann. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K113435 · Alfa Wassermann · Chemistry device
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Jul 2012
Decision
224d
Days
Class 2
Risk

K113435 is an FDA 510(k) clearance for the ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL B.... Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Alfa Wassermann (West Caldwell, US). The FDA issued a Cleared decision on July 2, 2012 after a review of 224 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1160 - 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 devices

Submission Details

510(k) Number K113435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2011
Decision Date July 02, 2012
Days to Decision 224 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
136d slower than avg
Panel avg: 88d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHS Enzymatic, Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1160
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 - KHS Enzymatic, Carbon-dioxide

All 66
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K113435.
Liquid CO2-2 (LCO2-2)
K152085 · Randox Laboratories, Ltd. · Feb 2016
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
K120765 · Ortho-Clinical Diagnostics, Inc. · Oct 2012
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781
K100289 · Siemens Healthcare Diagnostics · May 2010
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES
K093611 · Ortho-Clinical Diagnostics, Inc. · Apr 2010
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
K091153 · Beckman Coulter, Inc. · Jul 2009
CARBON DIOXIDE LIQUID STABLE REAGENT
K070251 · Pointe Scientific, Inc., · Apr 2007