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Levofloxacin Antimicrobial Susceptibility Test Disc

FDA 510(k)

Class II (US FDA 510(k))

510(k) K982519

by Oxoid Ltd

Identifiers

510(k) Number
K982519 FDA 510(k)
FDA Product Code
JTN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.1620 FDA 510(k)
Regulation Number
866.1620 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Levofloxacin Antimicrobial Susceptibility Test Disc is a susceptibility test disc used for in vitro antimicrobial susceptibility testing. It falls under the category of susceptibility test discs and is designed to determine the sensitivity of microorganisms to levofloxacin, aiding in the selection of appropriate antimicrobial therapy.

This disc is intended for use in the semi-quantitative agar diffusion test method within microbiology laboratories. Supplied as a single-use item, it is regulated under FDA 510(k) clearance (K982519) and classified as a Class II medical device. It is used in diagnostic workflows to assist clinicians in evaluating potential treatment options for microbial infections.

Frequently asked questions

What is the Levofloxacin Antimicrobial Susceptibility Test Disc used for in a clinical setting?

This disc is designed for in vitro antimicrobial susceptibility testing to determine how sensitive specific microorganisms are to levofloxacin. By measuring the inhibition zone around the disc during the semi-quantitative agar diffusion test, clinicians can evaluate whether levofloxacin may be an effective treatment option for infections caused by those microorganisms.

Is the Levofloxacin Antimicrobial Susceptibility Test Disc intended for single-use or repeated use?

The disc is explicitly supplied as a single-use item, meaning each disc should be used once and then discarded. This ensures accurate and reliable test results, as reuse could compromise sterility and performance.

What type of testing method does this disc support, and where is it typically used?

The disc is intended for use in the semi-quantitative agar diffusion test method, a standard technique in microbiology laboratories. It helps determine microbial resistance or susceptibility to levofloxacin, guiding antimicrobial therapy decisions.

How is the Levofloxacin Antimicrobial Susceptibility Test Disc regulated, and what does that mean for buyers?

This disc is classified as a Class II medical device and has received FDA 510(k) clearance (K982519) under the Traditional review pathway. This means it has been deemed substantially equivalent to a legally marketed device and meets regulatory standards for safety and effectiveness in antimicrobial susceptibility testing.

Does the disc require any special handling or storage conditions?

While the provided data does not specify storage conditions, as a single-use antimicrobial susceptibility test disc, it should be stored in a clean, dry environment protected from contamination and extreme temperatures. Always follow manufacturer guidelines to maintain sterility and integrity until use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Oxoid™ Levofloxacin Antimicrobial Susceptibility discs, Thermo Scientific Oxoid Levofloxacin Antimicrobial Susceptibility discs ..., PDF Antimicrobial Susceptibility Test Discs - Thermo Fisher Scientific

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Oxoid Ltd
FDA Applicant
Oxoid , Ltd.

Sources (1)

  • FDA 510(k) K982519 24 fields · synced Sep 19, 2026