Cleared Traditional

K002354 - CARBON DIOXIDE-L3K-C ASSAY

K002354 is the FDA 510(k) clearance for CARBON DIOXIDE-L3K-C ASSAY by Diagnostic Chemicals , Ltd.. It is a Class 2 Toxicology device (product code KHS) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K002354 · Diagnostic Chemicals , Ltd. · Toxicology device
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Sep 2000
Decision
55d
Days
Class 2
Risk

K002354 is an FDA 510(k) clearance for the CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80. Classified as Enzymatic, Carbon-dioxide (product code KHS), Class II - Special Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on September 26, 2000 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1160 - the FDA toxicology device 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 Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K002354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2000
Decision Date September 26, 2000
Days to Decision 55 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 87d · This submission: 55d
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 Toxicology 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 K002354.
COBAS INTEGRA CARBON DIOXIDE ASSAY
K031879 · Roche Diagnostics Corp. · Jul 2003
ANALYST PANELS + ANALYTICAL TEST ROTOR
K010864 · Hemagen Diagnostics, Inc. · May 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · Dade Behring, Inc. · Mar 2001
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
K001133 · Ortho-Clinical Diagnostics, Inc. · Apr 2000
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
K990754 · Diagnostic Chemicals , Ltd. · Apr 1999
CARBON DIOXIDE-SL ASSAY, CAT # 253-01
K983019 · Diagnostic Chemicals , Ltd. · Sep 1998