Cleared Traditional

K033809 - DIMENSION LIDOCAINE (LIDO) FLEX REAGENT...

K033809 is the FDA 510(k) clearance for DIMENSION LIDOCAINE (LIDO) FLEX REAGENT... by Dade Behring, Inc.. It is a Class 2 Toxicology device (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

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 13
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