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 862.3300](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3300) → LFM — Enzyme Immunoassay, Digitoxin

# LFM · Enzyme Immunoassay, Digitoxin

_Clinical Toxicology · 21 CFR 862.3300 · Class 2_

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

## Overview

- **Product Code:** LFM
- **Device Name:** Enzyme Immunoassay, Digitoxin
- **Regulation:** [21 CFR 862.3300](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3300)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

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

## Classification Rationale

Class II.

## Recent Cleared Devices (20 of 20)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K062024](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K062024.md) | DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Jul 28, 2006 | SESE |
| [K012112](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K012112.md) | RANDOX DIGITOXIN | Randox Laboratories, Ltd. | Jan 11, 2002 | SESE |
| [K990251](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K990251.md) | DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 | Dade Behring, Inc. | Mar 31, 1999 | SESE |
| [K970546](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K970546.md) | ACS DIGITOXIN | Chiron Diagnostics Corp. | Jul 14, 1997 | SESE |
| [K963158](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K963158.md) | ABBOTT AXSYM DIGITOXIN (MODIFY) | Abbott Laboratories | Sep 10, 1996 | SESE |
| [K954420](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K954420.md) | AXSYM DIGITOXIN | Abbott Laboratories | Dec 29, 1995 | SESE |
| [K951631](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K951631.md) | DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS | Bayer Corp. | Jun 9, 1995 | SESE |
| [K943235](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K943235.md) | IMMULITE DIGITOXIN | Diagnostic Products Corp. | Oct 27, 1994 | SESE |
| [K942610](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K942610.md) | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) | Eastman Kodak Company | Oct 20, 1994 | SESE |
| [K942619](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K942619.md) | EMIT 2000 DIGOXIN ASSAY/CALIBRATORS | Syva Co. | Sep 20, 1994 | SESE |
| [K915465](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K915465.md) | DIGITOXIN FPIA REAGENT SET | Sigma Diagnostics, Inc. | Jan 27, 1992 | SESE |
| [K913187](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K913187.md) | INNOFLUOR(TM) DIGITOXIN REAGENT SET | Intl. Bioclinical, Inc. | Sep 23, 1991 | SESE |
| [K913240](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K913240.md) | DIGITOXIN (FPIA) KIT | Tudor Laboratories, Inc. | Sep 6, 1991 | SESE |
| [K900013](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K900013.md) | MILENIA (TM) DIGITOXIN | Diagnostic Products Corp. | Mar 9, 1990 | SESE |
| [K896021](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K896021.md) | CEDIA DIGITOXIN ASSAY | Microgenics Corp. | Nov 8, 1989 | SESE |
| [K891094](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K891094.md) | ACA(R) DIGITOXIN (DGTX) METHOD | E.I. Dupont DE Nemours & Co., Inc. | Apr 26, 1989 | SESE |
| [K862067](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K862067.md) | STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | Jun 16, 1986 | SESE |
| [K842280](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K842280.md) | TDX DIGITOXIN | Abbott Laboratories | Aug 16, 1984 | SESE |
| [K842578](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K842578.md) | SOPHEIA/MP DIGITOXIN EIA KIT | Diagnostic Products Corp. | Aug 12, 1984 | SESE |
| [K830035](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LFM/K830035.md) | SOPHEIA DIGITOXIN EIA KIT & COMPONENTS | Diagnostic Products Corp. | Jan 28, 1983 | SESE |

## Top Applicants

- Diagnostic Products Corp. — 4 clearances
- Abbott Laboratories — 3 clearances
- Dade Behring, Inc. — 2 clearances
- American Dade — 1 clearance
- Bayer Corp. — 1 clearance

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

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