Cleared Traditional

K131546 - AU BICARBONATE REAGENT

K131546 is an FDA 510(k) clearance for AU BICARBONATE REAGENT, manufactured by Beckman Coulter Ireland, Inc.. The device is a Class 2 Chemistry device with product code KHS cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K131546 · Beckman Coulter Ireland, Inc. · Chemistry device
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Oct 2013
Decision
133d
Days
Class 2
Risk

K131546 is an FDA 510(k) clearance for the AU BICARBONATE REAGENT. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Beckman Coulter Ireland, Inc. (Brea, US). The FDA issued a Cleared decision on October 9, 2013 after a review of 133 days - within the typical 510(k) review window.

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 Beckman Coulter Ireland, Inc. devices

FDA 510(k) Submission Details - K131546

510(k) Number K131546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2013
Decision Date October 09, 2013
Days to Decision 133 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
45d slower than avg
Panel avg: 88d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHS Device Classification - Class 2, Special Controls

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 83
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K131546.
Carbon Dioxide Reagent Set
K170200 · Teco Diagnostics, Inc. · Jun 2017
Liquid CO2-2 (LCO2-2)
K152085 · Randox Laboratories, Ltd. · Feb 2016
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
K140248 · Hitachi Chemical Diagnostics, Inc. · Mar 2014
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K123953 · Alfa Wassermann Diagnostic Technologies, Inc. · May 2013
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
K120765 · Ortho-Clinical Diagnostics, Inc. · Oct 2012
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K113435 · Alfa Wassermann · Jul 2012