Cleared Traditional

QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM (K023058) - FDA 510(k) Clearance

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

K023058 · Seradyn · Toxicology device
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Oct 2002
Decision
41d
Days
Class 2
Risk

K023058 is an FDA 510(k) clearance for the QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Seradyn (Indianapolis, US). The FDA issued a Cleared decision on October 24, 2002 after a review of 41 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 Seradyn devices

Submission Details

510(k) Number K023058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2002
Decision Date October 24, 2002
Days to Decision 41 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 87d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXT Enzyme Immunoassay, Digoxin
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 - KXT Enzyme Immunoassay, Digoxin

All 84
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K023058.
ADVIA Centaur® Digoxin assay
K193397 · Siemens Healthcare Diagnostics, Inc. · Jul 2021
AXSYM DIGOXIN III
K061249 · Abbott Laboratories · Jun 2006
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · Diagnostic Products Corp. · Sep 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
K983151 · Beckman Coulter, Inc. · Nov 1998
SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR
K982935 · Beckman Coulter, Inc. · Oct 1998
ELECSYS DIGOXIN
K973112 · Boehringer Mannheim Corp. · Oct 1997