Cleared Traditional

K840596 - QUINIDINE ANALYTICAL TEST PACK

K840596 is the FDA 510(k) clearance for QUINIDINE ANALYTICAL TEST PACK by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Toxicology device (product code LBZ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K840596 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Apr 1984
Decision
55d
Days
Class 2
Risk

K840596 is an FDA 510(k) clearance for the QUINIDINE ANALYTICAL TEST PACK. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 55 days - a notably fast clearance 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: 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K840596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1984
Decision Date April 04, 1984
Days to Decision 55 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 87d · This submission: 55d
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 21
Devices cleared under the same product code (LBZ) and FDA review panel - the closest regulatory comparables to K840596.
COBAS FP REAGENTS FOR QUINIDINE
K850808 · Roche Diagnostic Systems, Inc. · Mar 1985
STRATUS QUINIDINE FLUOROMETRIC ENZYME
K843237 · American Dade · Sep 1984
TDX DISOPYRAMIDE
K842713 · Abbott Laboratories · Aug 1984
QUINIDINE FLUORESCENT IMMUNOASSAY
K832493 · American Diagnostic Corp. · Sep 1983
EMIT CAD QUINIDINE ASSAY FOR USE W/
K832096 · Syva Co. · Aug 1983
QUINIDINE REAGENT TEST KIT
K830963 · Beckman Instruments, Inc. · Jun 1983