Cleared Traditional

DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D (K033809) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033809 · Dade Behring, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Feb 2004
Decision
74d
Days
Class 2
Risk

K033809 is an FDA 510(k) clearance for the DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALI.... Classified as Enzyme Immunoassay, Lidocaine (product code KLR), Class II - Special Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3555 - 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K033809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2003
Decision Date February 20, 2004
Days to Decision 74 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 87d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLR Enzyme Immunoassay, Lidocaine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3555
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 - KLR Enzyme Immunoassay, Lidocaine

All 16
Devices cleared under the same product code (KLR) and FDA review panel - the closest regulatory comparables to K033809.
MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY
K833623 · Syva Co. · Dec 1983
MODIFICA- OF EMIT CAD LIDOCAINE ASSAY
K832799 · Syva Co. · Oct 1983
EMIT QST LIDOCAINE ASSAY
K831354 · Syva Co. · May 1983
ADVANCE EMIT CAD DISOPYRAMIDE ASSAY
K823887 · Syva Co. · Jan 1983
ADVANCE EMIT CAD LIDOCAINE ASSAY
K823866 · Syva Co. · Jan 1983
CYBREX LIDOCAINE
K802131 · Abbott Laboratories · Oct 1980