BD BBL Sensi-Disc Lefamulin 20µg (LMU-20)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230651 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 BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) is an antimicrobial susceptibility test disc used to determine bacterial susceptibility to lefamulin. Classified as a susceptibility test disc under the device nomenclature for microbiology, it adheres to standardized antimicrobial testing protocols to assess microbial resistance patterns in clinical laboratories.
This disc is supplied as a single-use item for in vitro diagnostic use in microbiology settings, complying with FDA 510(k) clearance (K230651) and IVDR requirements. It is intended for use in automated or manual susceptibility testing systems, with no MRI safety considerations specified. Storage conditions and shelf life are detailed in the package insert, and regulatory compliance is maintained through the assigned product codes (JTN) and registration numbers.
Frequently asked questions
What is the BD BBL Sensi-Disc Lefamulin 20µg disc used for in a clinical lab setting?
The BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) is designed specifically for in vitro antimicrobial susceptibility testing to evaluate how bacteria respond to lefamulin. It helps laboratories determine whether bacterial isolates are susceptible, intermediate, or resistant to this antibiotic, which is critical for guiding appropriate treatment decisions. The disc adheres to standardized protocols and is classified under susceptibility test discs for microbiology use.
Is the BD BBL Sensi-Disc Lefamulin 20µg disc single-use or reusable?
This disc is strictly single-use only, as indicated in the product description. It is intended for one-time use in antimicrobial susceptibility testing to ensure accuracy and prevent cross-contamination. Discarding after use is essential for maintaining test integrity and compliance with microbiology best practices.
How should the BD BBL Sensi-Disc Lefamulin 20µg be stored, and what is its shelf life?
Storage conditions and shelf life details are provided in the package insert, which must be consulted for precise instructions. However, the disc is designed for in vitro diagnostic use and requires adherence to standard microbiology storage protocols to preserve its efficacy. Always follow the manufacturer’s guidelines to avoid compromising test reliability.
What regulatory pathways does the BD BBL Sensi-Disc Lefamulin 20µg follow, and how does it comply with global standards?
The disc holds FDA 510(k) clearance (K230651) under the Traditional pathway, classified as substantially equivalent to a predicate device, and complies with In Vitro Diagnostic Regulation (IVDR) requirements. It is categorized under product code JTN and falls under the Microbiology advisory committee (MI). These pathways ensure its suitability for antimicrobial susceptibility testing in clinical laboratories.
Can this disc be used with both automated and manual susceptibility testing systems?
Yes, the BD BBL Sensi-Disc Lefamulin 20µg is compatible with both automated and manual antimicrobial susceptibility testing systems. Its design aligns with standardized protocols, making it versatile for integration into various laboratory workflows while maintaining accuracy in resistance pattern assessment.
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: BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) (K230651) — FDA 510(k ..., K230651 - BD BBL Sensi-Disc Lefamulin 20µg (LMU-20), Becton Dickinson – Wikipedia, PDF K230651 - BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
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 | K230651 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (2)
- FDA 510(k) K230651 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 28, 2026