Bd Phoenix Automated Microbiology System - Ceftaroline (0.625-4 Ug/Ml)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140468 FDA 510(k)
- FDA Product Code
- LON FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1645 FDA 510(k)
- Regulation Number
- 866.1645 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Phoenix Automated Microbiology System Ceftaroline (0.625–4 µg/mL) is an automated antimicrobial susceptibility testing system designed for microbiology laboratories. It identifies bacterial isolates and determines their susceptibility to ceftaroline, a cephalosporin antibiotic, enabling rapid and standardized antimicrobial profiling for clinical decision-making.
This system is intended for use in clinical microbiology laboratories and operates as a reusable, non-sterile instrument. It adheres to FDA 510(k) clearance under regulation 866.1645, classified as a Class II device for automated antimicrobial susceptibility testing. The system supports short incubation times and is regulated under the Medical Specialty of Microbiology, with no third-party certification required.
Frequently asked questions
What is the primary purpose of the BD Phoenix Automated Microbiology System – Ceftaroline, and how does it benefit clinical decision-making?
The BD Phoenix Automated Microbiology System – Ceftaroline is designed to identify bacterial isolates and determine their susceptibility to ceftaroline, a cephalosporin antibiotic. It enables rapid and standardized antimicrobial susceptibility testing, which helps clinicians make faster, more informed decisions about patient treatment by providing clear data on which bacteria are resistant or sensitive to ceftaroline.
Is the BD Phoenix Automated Microbiology System – Ceftaroline a single-use or reusable device, and what does that mean for my lab’s workflow?
The system itself is reusable and non-sterile, meaning it can be used repeatedly in your lab after proper cleaning and maintenance. However, the consumables (such as test panels or media) used within the system are likely single-use, as is typical for automated microbiology systems. This design allows for consistent performance while minimizing cross-contamination risks between tests.
How does the BD Phoenix Automated Microbiology System – Ceftaroline differ from other antimicrobial susceptibility testing systems in terms of speed?
This system is explicitly designed for *short incubation times*, which means it can provide results more quickly than traditional methods. While exact turnaround times aren’t specified, the emphasis on rapid testing aligns with clinical needs for faster antimicrobial profiling, reducing delays in patient care compared to manual or longer automated methods.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for compliance in my lab?
The BD Phoenix Automated Microbiology System – Ceftaroline received FDA clearance through a 510(k) submission, classified as *Substantially Equivalent* under regulation 866.1645 for automated antimicrobial susceptibility testing. This means the device meets FDA standards for safety and effectiveness, and your lab must ensure proper training and adherence to manufacturer instructions to maintain compliance with FDA guidelines for microbiology testing.
Does this system require third-party certification for use in a clinical microbiology lab?
No, the system does not require third-party certification for use. The FDA clearance and classification under Medical Specialty of Microbiology (with no third-party flag) indicate it is intended for direct integration into clinical microbiology labs without additional external validation steps, provided the lab follows the manufacturer’s operational guidelines and regulatory requirements.
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 Phoenix Automated Microbiology System - Ceftaroline (0.625-4 Ug/Ml ..., Bd Phoenix Automated Microbiology System - Ceftaroline (0.625-4 Ug/Ml), Bd Phoenix Automated Microbiology System - Ceftaroline (0.625-4 Ug/Ml ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140468 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K140468 24 fields · synced Sep 18, 2026