Cleared Traditional

K032334 - ROCHE ONLINE TDM LIDOCAINE

K032334 is an FDA 510(k) clearance for ROCHE ONLINE TDM LIDOCAINE, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K032334

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.

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 Chemistry 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 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