BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks
by Becton, Dickinson and Company
510(k) K152516
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK152516 | Date13 Oct 2015 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- JTN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1620
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The BD BBL Sensi-Disc Ceftazidime Avibactam (30/20 µg) Antimicrobial Susceptibility Test Discs are antimicrobial susceptibility test discs designed for in vitro testing of bacterial isolates. These discs adhere to the Susceptibility Test Discs, Antimicrobial nomenclature and employ the Bauer-Kirby disc diffusion method to determine bacterial resistance or susceptibility to ceftazidime combined with avibactam.
These discs are supplied as single-use items for microbiology laboratories and are intended for semi-quantitative testing of bacterial pathogens. They are regulated under the In Vitro Diagnostic Regulation (IVDR) and have received FDA 510(k) clearance as substantially equivalent to a predicate device. Storage and handling follow standard microbiological practices to ensure accuracy and reliability of results.
From the manufacturer
The BD BBL™ Sensi-Disc™ portfolio provides labs with an accurate, convenient, and broad range of disk diffusion solutions. One of the latest additions to our FDA-approved disk diffusion test portfolio is the Cefiderocol 30µg disc (232255).
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the BD BBL Sensi-Disc Ceftazidime Avibactam (30/20 µg) discs in a clinical lab?
These discs are designed for in vitro antimicrobial susceptibility testing to determine whether bacterial isolates are resistant or susceptible to the combination of ceftazidime and avibactam. They use the Bauer-Kirby disc diffusion method, a standard microbiological technique, to provide semi-quantitative results for guiding infection treatment decisions.
Are these discs meant for single-use only, and if so, why?
Yes, these discs are single-use items intended exclusively for microbiology laboratories. The manufacturer specifies this to ensure accuracy and reliability of susceptibility testing results, as reuse could compromise sterility, disc integrity, or test consistency—critical factors in antimicrobial resistance assessment.
How should these discs be stored, and what storage conditions are recommended?
Storage follows standard microbiological practices, though exact conditions aren’t detailed in the data. Generally, antimicrobial susceptibility test discs like these are stored dry, protected from light, and at controlled room temperature (typically 2–25°C) to preserve potency and sterility until use. Always refer to the accompanying documentation for lab-specific protocols.
What regulatory pathways have these discs undergone, and how does that affect their use?
The discs received FDA 510(k) clearance under the Traditional pathway, declared *substantially equivalent* to a predicate device, and comply with the In Vitro Diagnostic Regulation (IVDR) in the EU. This means they meet U.S. and EU standards for antimicrobial susceptibility testing, ensuring validated performance for clinical decision-making—but compliance with local regulations (e.g., IVDR requirements) may still apply in specific regions.