Cleared Traditional

K032332 - ROCHE ONLINE TDM QUINIDINE

K032332 is the FDA 510(k) clearance for ROCHE ONLINE TDM QUINIDINE by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code LBZ) cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K032332 · Roche Diagnostics Corp. · Toxicology device
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Jan 2004
Decision
167d
Days
Class 2
Risk

K032332 is an FDA 510(k) clearance for the ROCHE ONLINE TDM QUINIDINE. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), 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 Toxicology FDA review panel, regulated under 21 CFR 862.3320 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K032332 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 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
80d slower than avg
Panel avg: 87d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBZ Enzyme Immunoassay, Quinidine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - LBZ Enzyme Immunoassay, Quinidine

All 19
Devices cleared under the same product code (LBZ) and FDA review panel - the closest regulatory comparables to K032332.
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964116 · Bayer Corp. · Dec 1996
QUINIDINE ENZYME IMMUNOASSAY
K964212 · Diagnostic Reagents, Inc. · Dec 1996
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
K941440 · Roche Diagnostic Systems, Inc. · Jul 1994
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
K922913 · Syva Co. · Aug 1992
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS
K904990 · Syva Co. · Feb 1991
TDXR FLECAINIDE
K872175 · Abbott Laboratories · Aug 1987