Cleared Traditional

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

K033809 is an FDA 510(k) clearance for DIMENSION LIDOCAINE (LIDO) FLEX REAGENT..., manufactured by Dade Behring, Inc.. The device is a Class 2 Toxicology device with product code KLR cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K033809 · Dade Behring, Inc. · Toxicology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K033809

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.

KLR Device Classification - Class 2, Special Controls

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 14
Devices cleared under the same product code (KLR) and FDA review panel - the closest regulatory comparables to K033809.
ROCHE ONLINE TDM LIDOCAINE
K032334 · Roche Diagnostics Corp. · Jan 2004
LIDOCAINE EIA ASSAY
K973102 · Diagnostic Reagents, Inc. · Sep 1997
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
K853010 · Roche Diagnostic Systems, Inc. · Aug 1985
STRATUS LIDOCAINE FLUOROMETRIC ENZYME
K843184 · American Dade · Sep 1984
LIDOCAINE ANALYTICAL TEST PACK ACA
K833379 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
VALPROIC ACID ANALYTICAL TEST PACK
K833381 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983