Cleared Traditional

K060619 - DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT

K060619 is an FDA 510(k) clearance for DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, manufactured by Diazyme Laboratories. The device is a Class 2 Chemistry device with product code KHS cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K060619 · Diazyme Laboratories · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 2006
Decision
135d
Days
Class 2
Risk

K060619 is an FDA 510(k) clearance for the DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Diazyme Laboratories (San Diego, US). The FDA issued a Cleared decision on July 21, 2006 after a review of 135 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 Diazyme Laboratories devices

FDA 510(k) Submission Details - K060619

510(k) Number K060619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2006
Decision Date July 21, 2006
Days to Decision 135 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
47d slower than avg
Panel avg: 88d · This submission: 135d
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 74
Devices cleared under the same product code (KHS) and FDA review panel - the closest regulatory comparables to K060619.
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
K091153 · Beckman Coulter, Inc. · Jul 2009
S-TEST C02
K073223 · Alfa Wassermann Diagnostic Technologies, Inc. · Jun 2008
CARBON DIOXIDE LIQUID STABLE REAGENT
K070251 · Pointe Scientific, Inc., · Apr 2007
DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
K061238 · Dade Behring, Inc. · May 2006
CARBON DIOXIDE
K060295 · Abbott Laboratories · 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