Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart B — Diagnostic Devices](/submissions/MI/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 866.1620](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1620) → LTX — Discs, Elution

# LTX · Discs, Elution

_Microbiology · 21 CFR 866.1620 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTX

## Overview

- **Product Code:** LTX
- **Device Name:** Discs, Elution
- **Regulation:** [21 CFR 866.1620](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/866.1620)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)
- **3rd-party reviewable:** yes

## Identification

An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K002139](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTX/K002139.md) | ETEST LINEZOLID | Ab Biodisk | Nov 8, 2000 | SESE |
| [K992993](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTX/K992993.md) | ETEST FOR QUINUPRISTIN/DALFOPRISTIN | Ab Biodisk | Nov 16, 1999 | SESE |

## Top Applicants

- Ab Biodisk — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTX](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTX)

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