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) → LGJ — Fluorescence Polarization Immunoassay, Amibacin

# LGJ · Fluorescence Polarization Immunoassay, Amibacin

_Clinical Toxicology · 21 CFR 862.3035 · Class 2_

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

## Overview

- **Product Code:** LGJ
- **Device Name:** Fluorescence Polarization Immunoassay, Amibacin
- **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 |
| --- | --- | --- | --- | --- |
| [K991597](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGJ/K991597.md) | COBAS INTEGRA AMIKACIN MAB | Roche Diagnostics Corp. | Jul 22, 1999 | SESE |
| [K941712](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGJ/K941712.md) | COBAS-FP REAGENTS AND CALIBRATORS | Roche Diagnostic Systems, Inc. | Jun 13, 1994 | SESE |
| [K862248](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGJ/K862248.md) | AMIKACIN KIT (FPIA) | Windsor Laboratories, Inc. | Aug 4, 1986 | SESE |

## Top Applicants

- Roche Diagnostic Systems, Inc. — 1 clearance
- Roche Diagnostics Corp. — 1 clearance
- Windsor Laboratories, Inc. — 1 clearance

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

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