Cleared Traditional

K032334 - ROCHE ONLINE TDM LIDOCAINE

K032334 is the FDA 510(k) clearance for ROCHE ONLINE TDM LIDOCAINE by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code KLR) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K032334 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
167d
Days
Class 2
Risk

K032334 is an FDA 510(k) clearance for the ROCHE ONLINE TDM LIDOCAINE. Classified as Enzyme Immunoassay, Lidocaine (product code KLR), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 12, 2004 after a review of 167 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3555 - 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K032334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2003
Decision Date January 12, 2004
Days to Decision 167 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
79d slower than avg
Panel avg: 88d · This submission: 167d
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 Chemistry 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 K032334.
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D
K033809 · Dade Behring, Inc. · Feb 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