Moxifloxacin Antimicrobial Susceptibility Test Disc
FDA 510(k)Class II (US FDA 510(k))
by Oxoid Ltd
Identifiers
- 510(k) Number
- K010536 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. It is designed to determine the susceptibility of microorganisms to moxifloxacin, a fluoroquinolone antibiotic, using manual antimicrobial susceptibility testing (AST) methods. The disc delivers a standardized concentration of 5 micrograms of moxifloxacin to assess bacterial resistance or sensitivity in vitro. It adheres to clinical microbiology standards for reliable and reproducible results.
The disc is supplied as a single-use item for manual AST procedures in microbiology laboratories. It is intended for use with standard microbiological techniques, including agar diffusion methods, and requires no additional sterilization beyond standard laboratory practices. Compliance with regulatory standards is ensured through FDA 510(k) clearance under the Traditional pathway, with the device classified as Class II. Storage conditions follow general antimicrobial susceptibility testing guidelines to maintain disc integrity and potency.
Frequently asked questions
What is the moxifloxacin antimicrobial susceptibility test disc used for?
This disc is designed for manual antimicrobial susceptibility testing (AST) to determine whether bacteria are resistant or sensitive to moxifloxacin, a fluoroquinolone antibiotic. It delivers a precise 5 microgram concentration of the drug, allowing laboratories to assess bacterial response in vitro using standard agar diffusion methods. This helps guide appropriate antibiotic therapy decisions based on clinical microbiology standards.
How is the moxifloxacin susceptibility test disc supplied and used?
The disc is supplied as a single-use item, meaning each disc is intended for one AST procedure only. It requires no additional sterilization beyond standard laboratory practices. Laboratories apply it directly to agar plates seeded with bacterial cultures, following established microbiological techniques for agar diffusion testing. This ensures accurate and reproducible results without cross-contamination.
Is the moxifloxacin AST disc sterile and reusable?
The disc is not sterile beyond standard laboratory handling—it is intended for single-use only. Sterility is not required for this type of susceptibility testing, as the disc is designed to be used in controlled microbiology environments where contamination risks are mitigated through standard aseptic techniques. Reuse is not recommended, as it could compromise test accuracy.
What storage conditions are recommended for the moxifloxacin susceptibility test disc?
Storage follows general antimicrobial susceptibility testing guidelines to preserve disc integrity and potency. The disc should be kept in a dry, cool environment, protected from direct light and moisture. Avoid exposure to extreme temperatures or humidity, as these factors can degrade the disc’s antimicrobial properties. Always refer to the manufacturer’s instructions for specific storage details.
What regulatory pathway does the moxifloxacin AST disc follow?
The disc is cleared by the FDA under the Traditional 510(k) pathway, classified as substantially equivalent to a predicate device. It was reviewed by the Microbiology (MI) Advisory Committee and falls under product code JTN, with a device classification of Class II. This pathway ensures compliance with U.S. regulatory standards for antimicrobial susceptibility testing devices.
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™ Moxifloxacin Antimicrobial Susceptibility discs, Oxoid™ Moxifloxacin Antimicrobial Susceptibility discs 5 μg | Request ..., Thermo Scientific Oxoid Moxifloxacin Antimicrobial Susceptibility discs ..., Thermo Scientific Oxoid Moxifloxacin 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 | K010536 | Class II | Active |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- FDA Applicant
- Oxoid , Ltd.
Sources (1)
- FDA 510(k) K010536 24 fields · synced Oct 1, 2026