Tigecycline Antimicrobial Susceptibility Test Disc
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Oxoid Ltd
Identifiers
- 510(k) Number
- K060286 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)
This device is an antimicrobial susceptibility test disc, classified under susceptibility test discs, used to determine the in vitro susceptibility of microorganisms to tigecycline. It adheres to the nomenclature for antimicrobial susceptibility testing, specifically the semi-quantitative agar diffusion method, which evaluates microbial resistance patterns for clinical decision-making.
The Tigecycline Antimicrobial Susceptibility Test Disc is supplied for manual antimicrobial susceptibility testing (AST) in microbiology laboratories. It is intended for single-use and requires sterile handling, with results interpreted based on zone diameters measured against standardized criteria. Authorized under FDA 510(k) clearance and IVDR compliance, it is categorized under device class II for regulatory oversight. Discs are available in specific reference codes (e.g., CT1841B) and sizes (e.g., 15µg).
Frequently asked questions
What is the Tigecycline Antimicrobial Susceptibility Test Disc used for in a clinical setting?
This disc is designed for in vitro antimicrobial susceptibility testing (AST) to evaluate how sensitive specific microorganisms are to tigecycline. By measuring the zone of inhibition around the disc on agar plates, laboratories can determine whether bacteria are likely resistant or susceptible, which helps guide clinical treatment decisions.
How is the Tigecycline Antimicrobial Susceptibility Test Disc supplied, and is it reusable?
The disc is supplied for manual antimicrobial susceptibility testing in microbiology labs and is intended for single-use only. Each disc must be handled under sterile conditions to ensure accurate results, as reuse is not permitted.
What size and reference code should I look for when ordering this test disc?
The Tigecycline disc is available in a 15µg concentration and can be ordered using the reference code CT1841B. Always verify the exact code with the manufacturer to ensure compatibility with your lab’s testing protocols.
How are the results of this test interpreted, and what method is used?
Results are interpreted using the semi-quantitative agar diffusion method, where the size of the inhibition zone around the disc is measured in millimeters. These measurements are compared against standardized criteria to determine susceptibility or resistance to tigecycline.
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™ Tigecycline Antimicrobial Susceptibility discs, Thermo Scientific Oxoid Tigecycline Antimicrobial Susceptibility discs ..., PDF Oxoid Tigecycline Discs 15µg (TGC15) CT1841B Antimicrobial ...
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K060286 | Class II | Active |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- FDA Applicant
- Oxoid , Ltd.
Sources (2)
- FDA 510(k) K060286 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026