Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3320](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3320) → DKA — Antiserum, Digoxin

# DKA · Antiserum, Digoxin

_Clinical Toxicology · 21 CFR 862.3320 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKA

## Overview

- **Product Code:** DKA
- **Device Name:** Antiserum, Digoxin
- **Regulation:** [21 CFR 862.3320](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3320)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

## Classification Rationale

Class II.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K934003](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKA/K934003.md) | STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | Nov 22, 1994 | SESE |
| [K780498](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKA/K780498.md) | CBR-DIGOXIN ANTISERUM | Clinical Bioresearch | Apr 5, 1978 | SESE |
| [K780316](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKA/K780316.md) | RABBIT ANTIBODY TO DIGOXIN | Pcl-Ria, Inc. | Mar 17, 1978 | SESE |

## Top Applicants

- Baxter Diagnostics, Inc. — 1 clearance
- Clinical Bioresearch — 1 clearance
- Pcl-Ria, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKA](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKA)

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