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) → DOY — Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.

# DOY · Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody 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/DOY

## Overview

- **Product Code:** DOY
- **Device Name:** Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K910154](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOY/K910154.md) | USCI ILLUMEN-8 8F PTCA GUIDING CATHETER | C.R. Bard, Inc. | Apr 9, 1991 | SESE |
| [K832396](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOY/K832396.md) | CENTRAL VENOUS ACCESS CATHETER CVAC | Gish Biomedical, Inc. | Aug 31, 1983 | SESE |
| [K831239](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOY/K831239.md) | WALRUS PERCUTANEOUS INTRODUCER SET | Medical Parameters, Inc. | May 25, 1983 | SESE |
| [K831191](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOY/K831191.md) | VASCULAR CATHETER | Medrad, Inc. | May 9, 1983 | SESE |
| [K831188](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOY/K831188.md) | CONNECTOR TUBE | Medrad, Inc. | May 9, 1983 | SESE |

## Top Applicants

- Medrad, Inc. — 2 clearances
- C.R. Bard, Inc. — 1 clearance
- Gish Biomedical, Inc. — 1 clearance
- Medical Parameters, Inc. — 1 clearance

---

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

**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