Cleared Traditional

TDX DISOPYRAMIDE (K842713) - FDA 510(k) Clearance

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

K842713 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1984
Decision
48d
Days
Class 2
Risk

K842713 is an FDA 510(k) clearance for the TDX DISOPYRAMIDE. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 29, 1984 after a review of 48 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 Abbott Laboratories devices

Submission Details

510(k) Number K842713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1984
Decision Date August 29, 1984
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
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 17
Devices cleared under the same product code (LBZ) and FDA review panel - the closest regulatory comparables to K842713.
EMIT QUINIDINE ASSAY
K862214 · Syva Co. · Jun 1986
COBAS FP REAGENTS FOR QUINIDINE
K850808 · Roche Diagnostic Systems, Inc. · Mar 1985
STRATUS QUINIDINE FLUOROMETRIC ENZYME
K843237 · American Dade · Sep 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