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 862.3035](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3035) → LDN — Enzymatic Radiochemical Assay, Amikacin

# LDN · Enzymatic Radiochemical Assay, Amikacin

_Clinical Toxicology · 21 CFR 862.3035 · Class 2_

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

## Overview

- **Product Code:** LDN
- **Device Name:** Enzymatic Radiochemical Assay, Amikacin
- **Regulation:** [21 CFR 862.3035](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3035)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.

## Classification Rationale

Class II.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K840647](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDN/K840647.md) | AMIKACIN REAGENT TEST KIT | Beckman Instruments, Inc. | Apr 2, 1984 | SESE |
| [K833546](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDN/K833546.md) | MODIFICATION OF EMIT AND AMIKACIN ASSAY | Syva Co. | Dec 8, 1983 | SESE |
| [K820440](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDN/K820440.md) | EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO | Syva Co. | Mar 15, 1982 | SESE |

## Top Applicants

- Syva Co. — 2 clearances
- Beckman Instruments, Inc. — 1 clearance

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

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