Cleared Traditional

K843237 - STRATUS QUINIDINE FLUOROMETRIC ENZYME

K843237 is the FDA 510(k) clearance for STRATUS QUINIDINE FLUOROMETRIC ENZYME by American Dade. It is a Class 2 Toxicology device (product code LBZ) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K843237 · American Dade · Toxicology device
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Sep 1984
Decision
21d
Days
Class 2
Risk

K843237 is an FDA 510(k) clearance for the STRATUS QUINIDINE FLUOROMETRIC ENZYME. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on September 12, 1984 after a review of 21 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 American Dade devices

Submission Details

510(k) Number K843237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1984
Decision Date September 12, 1984
Days to Decision 21 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
66d faster than avg
Panel avg: 87d · This submission: 21d
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 K843237.
EMIT QUINIDINE ASSAY
K862214 · Syva Co. · Jun 1986
DETERMINATION OF QUINIDINE
K860049 · Clinical Data, Inc. · Jan 1986
COBAS FP REAGENTS FOR QUINIDINE
K850808 · Roche Diagnostic Systems, Inc. · Mar 1985
TDX DISOPYRAMIDE
K842713 · Abbott Laboratories · Aug 1984
QUINIDINE ANALYTICAL TEST PACK
K840596 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1984
QUINIDINE FLUORESCENT IMMUNOASSAY
K832493 · American Diagnostic Corp. · Sep 1983