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 862.3280](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3280) → DMP — Digoxin Control Serum, Ria

# DMP · Digoxin Control Serum, Ria

_Clinical Toxicology · 21 CFR 862.3280 · Class 1_

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

## Overview

- **Product Code:** DMP
- **Device Name:** Digoxin Control Serum, Ria
- **Regulation:** [21 CFR 862.3280](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3280)
- **Device Class:** 1
- **Review Panel:** [Clinical Toxicology](/submissions/TX)

## Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K973973](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DMP/K973973.md) | ELECSYS CALLCHECK DIGOXIN | Boehringer Mannheim Corp. | Nov 4, 1997 | SESE |
| [K953393](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DMP/K953393.md) | TOX PERFECT A TUBE | Chimera Research & Chemical, Inc. | Oct 6, 1995 | SESE |
| [K780889](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DMP/K780889.md) | DIGOXIN STANDARDS IN HUMAN SERUM | Pcl-Ria, Inc. | Aug 14, 1978 | SESE |
| [K770411](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DMP/K770411.md) | DIGI TROL TM-RX & DIGI TROL TM-TX | Nuclear Medical Laboratories, Inc. | Mar 16, 1977 | SESE |

## Top Applicants

- Boehringer Mannheim Corp. — 1 clearance
- Chimera Research & Chemical, Inc. — 1 clearance
- Nuclear Medical Laboratories, Inc. — 1 clearance
- Pcl-Ria, Inc. — 1 clearance

---

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

**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