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) → DOA — Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

# DOA · Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.

_Clinical Toxicology · 21 CFR 862.3320 · Class 2_

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

## Overview

- **Product Code:** DOA
- **Device Name:** Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K032291](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOA/K032291.md) | TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM | Linde Medical Sensors AG | Aug 24, 2004 | SESE |

## Top Applicants

- Linde Medical Sensors AG — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com