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QMS Digoxin Reagent System on the Abbott Aeroset System

by Seradyn, Inc. 510(k)

Active United States

510(k) K023058

Overview

The QMS Digoxin Reagent System on the Abbott Aeroset System is a homogeneous particle enhanced turbidimetric immunoassay used for the quantitation of digoxin in human serum or plasma. It is intended for use on the Abbott Aeroset System and is substantially equivalent to a legally marketed predicate device as determined by FDA 510(k) clearance.

The device is supplied as a reagent system for in vitro diagnostic use in clinical laboratories. It has been cleared under FDA 510(k) number K023058 with product code KXT and is classified as a Class II medical device under regulation number 862.3320 for clinical toxicology.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023058 Date24 Oct 2002ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KXT
FDA applicant
Seradyn
Device Class
Class II
Regulation
21 CFR Part 862.3320
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the QMS Digoxin Reagent System used for?

    The QMS Digoxin Reagent System on the Abbott Aeroset System is used for the quantitation of digoxin in human serum or plasma, enabling clinical laboratories to measure digoxin levels for therapeutic drug monitoring.

  • How is the QMS Digoxin Reagent System supplied?

    The device is supplied as a reagent system for in vitro diagnostic use in clinical laboratories, designed specifically for use on the Abbott Aeroset System.

  • What regulatory pathway was used for the QMS Digoxin Reagent System?

    The QMS Digoxin Reagent System on the Abbott Aeroset System received FDA 510(k) clearance under number K023058, demonstrating substantial equivalence to a legally marketed predicate device.