Cleared Traditional

COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS (K941440) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941440 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1994
Decision
104d
Days
Class 2
Risk

K941440 is an FDA 510(k) clearance for the COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on July 6, 1994 after a review of 104 days - within the typical 510(k) review window.

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 Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K941440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1994
Decision Date July 06, 1994
Days to Decision 104 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 87d · This submission: 104d
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 26
Devices cleared under the same product code (LBZ) and FDA review panel - the closest regulatory comparables to K941440.
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
EMIT QUINIDINE ASSAY
K862214 · Syva Co. · Jun 1986
COBAS FP REAGENTS FOR QUINIDINE
K850808 · Roche Diagnostic Systems, Inc. · Mar 1985
TDX DISOPYRAMIDE
K842713 · Abbott Laboratories · Aug 1984