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Ciba Corning ACS Digoxin Immunoassay

by Ciba Corning Diagnostics Corp. 510(k)

Active United States

510(k) K902861

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902861 Date10 Sep 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
DON
Device Class
Class II
Regulation
21 CFR Part 862.3320
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ciba Corning ACS Digoxin Immunoassay is a radioimmunoassay for the quantitative measurement of digoxin in serum or plasma. It employs a solid-phase separation technique using a rabbit antibody conjugated with digoxin to detect and quantify the cardiac glycoside digoxin, which is commonly monitored in clinical toxicology for therapeutic drug management or overdose assessment.

This assay is supplied as a single-use diagnostic kit for in vitro diagnostic use in clinical laboratories. It requires FDA 510(k) clearance (K902861) under regulation 862.3320 and is classified as a Class II device (DON product code). The kit includes all necessary reagents for performing the assay, and proper storage conditions must be maintained as specified in the accompanying instructions. No third-party review or combination product authorization applies.

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