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) → KLP — Amikacin Serum Assay

# KLP · Amikacin Serum Assay

_Clinical Toxicology · 21 CFR 862.3035 · Class 2_

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

## Overview

- **Product Code:** KLP
- **Device Name:** Amikacin Serum Assay
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K032279](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLP/K032279.md) | ONLINE TDM AMIKA | Roche Diagnostics Corp. | Oct 10, 2003 | SESE |
| [K873426](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLP/K873426.md) | EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 | Em Diagnostic Systems, Inc. | Oct 29, 1987 | SESE |
| [K790899](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLP/K790899.md) | BACTEC | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 23, 1979 | SESE |
| [K780949](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLP/K780949.md) | BIO-MONITOR AMIKACIN | Monitor Science Corp. | Aug 14, 1978 | SESE |

## Top Applicants

- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Em Diagnostic Systems, Inc. — 1 clearance
- Monitor Science Corp. — 1 clearance
- Roche Diagnostics Corp. — 1 clearance

---

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

**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