Cleared Traditional

K091153 - SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) R...

K091153 is the FDA 510(k) clearance for SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) R... by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code KHS) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K091153 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Jul 2009
Decision
83d
Days
Class 2
Risk

K091153 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on July 13, 2009 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K091153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2009
Decision Date July 13, 2009
Days to Decision 83 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
5d faster than avg
Panel avg: 88d · This submission: 83d
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 65
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K091153.
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
CARBON DIOXIDE LIQUID STABLE REAGENT
K070251 · Pointe Scientific, Inc., · Apr 2007
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
K060619 · Diazyme Laboratories · Jul 2006
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
K061238 · Dade Behring, Inc. · May 2006