Oxoid Streptomycin Antimicrobial Susceptibility Test Disc
FDA 510(k)Class II (US FDA 510(k))
by Oxoid Ltd
Identifiers
- 510(k) Number
- K982669 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 Oxoid Streptomycin Antimicrobial Susceptibility Test Disc is a susceptibility test disc used for in vitro antimicrobial susceptibility testing. It falls under the category of antimicrobial susceptibility discs, designed to assess bacterial susceptibility to streptomycin via the agar diffusion method. This disc is part of a semi-quantitative testing system, enabling microbiologists to evaluate microbial resistance patterns in clinical isolates. The device aids in determining appropriate antimicrobial therapy by providing measurable zones of inhibition around the disc.
These discs are supplied as single-use items for manual antimicrobial susceptibility testing (AST) in microbiology laboratories. They are intended for use in conjunction with standard agar media and are not sterile for direct patient use. The device is regulated under FDA 510(k) clearance (K982669) and falls under Class II medical devices (device class 2). Storage requires protection from moisture and extreme temperatures, adhering to standard laboratory conditions for antimicrobial susceptibility discs. No MRI safety considerations apply, as the discs are non-metallic and non-magnetic.
Frequently asked questions
What is the Oxoid Streptomycin Antimicrobial Susceptibility Test Disc used for?
This disc is designed for in vitro antimicrobial susceptibility testing to determine bacterial resistance or susceptibility to streptomycin. By placing it on agar plates inoculated with bacterial isolates, microbiologists measure the zone of inhibition around the disc, which helps guide appropriate antimicrobial therapy decisions. It is part of a semi-quantitative system to assess microbial resistance patterns in clinical settings.
How is the Oxoid Streptomycin Antimicrobial Susceptibility Test Disc supplied and intended for use?
The disc is supplied as a single-use item for manual antimicrobial susceptibility testing in microbiology laboratories. It is not sterile for direct patient use but is intended for use alongside standard agar media to evaluate bacterial resistance. Each disc is meant for one-time use in a controlled laboratory environment.
Is the Oxoid Streptomycin Antimicrobial Susceptibility Test Disc sterile?
No, the disc is not sterile for direct patient use. It is intended for use in microbiology laboratories to test bacterial isolates on agar plates, where sterility is not required for the disc itself but is ensured through proper laboratory practices and sterile media preparation.
How should the Oxoid Streptomycin Antimicrobial Susceptibility Test Disc be stored?
Storage requires protection from moisture and extreme temperatures. The disc should be kept under standard laboratory conditions suitable for antimicrobial susceptibility discs to maintain its integrity and accuracy. Avoid exposing it to conditions that could compromise its performance.
Does the Oxoid Streptomycin Antimicrobial Susceptibility Test Disc have any MRI safety considerations?
No, the disc is non-metallic and non-magnetic, so there are no MRI safety concerns associated with its use. It is designed solely for in vitro testing in microbiology labs and does not interact with magnetic fields.
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™ Streptomycin Antimicrobial Susceptibility discs, Oxoid™ Trimethoprim/Sulfamethoxazole 1:19 Antimicrobial Susceptibility ..., Thermo Scientific Oxoid Streptomycin Antimicrobial Susceptibility discs ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982669 | Class II | Active |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- FDA Applicant
- Oxoid , Ltd.
Sources (1)
- FDA 510(k) K982669 24 fields · synced Oct 1, 2026