Cleared Traditional

K023058 - QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM

K023058 is an FDA 510(k) clearance for QMS DIGOXIN REAGENT SYSTEM ON THE ABBOT..., manufactured by Seradyn. The device is a Class 2 Toxicology device with product code KXT cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K023058 · Seradyn · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K023058

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.

KXT Device Classification - Class 2, Special Controls

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 79
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K023058.
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
K082953 · Biokit, S.A. · Dec 2008
AXSYM DIGOXIN III
K061249 · Abbott Laboratories · Jun 2006
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
K033007 · Bayer Diagnostics Corp. · Nov 2003
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · Diagnostic Products Corp. · Sep 2001
RANDOX DIGOXIN
K011302 · Randox Laboratories, Ltd. · Jul 2001
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
K011920 · Syva Co., Dade Behring, Inc. · Jul 2001