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Ertapenem Antimicrobial Susceptibility Test Disc

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K070262

by Oxoid Ltd

Identifiers

510(k) Number
K070262 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 Ertapenum Antimicrobial Susceptibility Test Disc is a diagnostic in vitro device used to determine bacterial susceptibility to the antimicrobial agent ertapenem. It falls under the category of susceptibility test discs, which are employed in microbiology to assess whether bacterial isolates are resistant or susceptible to specific antibiotics, aiding in appropriate antimicrobial therapy selection.

This disc is supplied as a single-use, non-sterile item for laboratory use in microbiology settings. It is regulated under the FDA’s 510(k) clearance process and the In Vitro Diagnostic Regulation (IVDR). The device is intended for use in conjunction with standard microbiological techniques, such as disk diffusion testing, and is classified as a Class II medical device under the FDA’s device classification system.

Frequently asked questions

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

This disc is designed for in vitro testing to determine whether bacterial isolates are resistant or susceptible to the antibiotic ertapenem. It helps microbiologists guide appropriate antimicrobial therapy by assessing bacterial sensitivity through standard disk diffusion testing methods.

Is the Ertapenum Antimicrobial Susceptibility Test Disc sterile, and how is it intended to be used?

The disc is supplied as a non-sterile item, intended exclusively for laboratory use in microbiology settings. Since it is single-use, it should be handled in a controlled environment following standard microbiological protocols to avoid contamination.

What regulatory pathways does this device follow, and how is it classified?

The disc is cleared via the FDA’s 510(k) process under the Traditional pathway and complies with the In Vitro Diagnostic Regulation (IVDR). It is classified as a Class II medical device under FDA guidelines, indicating moderate regulatory oversight.

Are there multiple sizes or models of this disc, or is it a single standardized format?

The data provided does not specify multiple sizes or models—it describes the disc as a single-use antimicrobial susceptibility test disc for ertapenem. Standardization aligns with typical disk diffusion testing protocols, ensuring consistent results across laboratories.

How should this disc be stored, and what precautions should be taken?

While the data does not detail storage conditions explicitly, as a non-sterile laboratory reagent, it should be stored in a dry, clean environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines (Oxoid Ltd.) to maintain 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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Oxoid Ltd
FDA Applicant
Oxoid , Ltd.

Sources (2)

  • FDA 510(k) K070262 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026