Cleared Traditional

K060295 - CARBON DIOXIDE

K060295 is an FDA 510(k) clearance for CARBON DIOXIDE, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code KHS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K060295 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
87d
Days
Class 2
Risk

K060295 is an FDA 510(k) clearance for the CARBON DIOXIDE. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 4, 2006 after a review of 87 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K060295

510(k) Number K060295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2006
Decision Date May 04, 2006
Days to Decision 87 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
1d faster than avg
Panel avg: 88d · This submission: 87d
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 65
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K060295.
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
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
K042362 · Diagnostic Chemicals , Ltd. · Dec 2004
ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID
K032377 · Roche Diagnostics Corp. · Aug 2003
COBAS INTEGRA CARBON DIOXIDE ASSAY
K031879 · Roche Diagnostics Corp. · Jul 2003