Cleared Traditional

K832493 - QUINIDINE FLUORESCENT IMMUNOASSAY

K832493 is the FDA 510(k) clearance for QUINIDINE FLUORESCENT IMMUNOASSAY by American Diagnostic Corp.. It is a Class 2 Chemistry device (product code LBZ) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K832493 · American Diagnostic Corp. · Chemistry device
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Sep 1983
Decision
47d
Days
Class 2
Risk

K832493 is an FDA 510(k) clearance for the QUINIDINE FLUORESCENT IMMUNOASSAY. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - 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: 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 Diagnostic Corp. devices

Submission Details

510(k) Number K832493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1983
Decision Date September 12, 1983
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
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 Chemistry 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 K832493.
STRATUS QUINIDINE FLUOROMETRIC ENZYME
K843237 · American Dade · Sep 1984
TDX DISOPYRAMIDE
K842713 · Abbott Laboratories · Aug 1984
QUINIDINE ANALYTICAL TEST PACK
K840596 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1984
EMIT CAD QUINIDINE ASSAY FOR USE W/
K832096 · Syva Co. · Aug 1983
QUINIDINE REAGENT TEST KIT
K830963 · Beckman Instruments, Inc. · Jun 1983
EMIT QST QUINIDINE ASSAY
K831355 · Syva Co. · Jun 1983