BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233986 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 - GN Ciprofloxacin (0.0156–4 µg/mL) is an automated antimicrobial susceptibility testing system designed for in vitro susceptibility testing of Gram-negative bacterial pathogens. It incorporates ciprofloxacin concentrations to evaluate bacterial resistance, enabling rapid and accurate detection of antimicrobial resistance patterns in clinical isolates.
This device is intended for use in microbiology laboratories and operates as a fully automated short-term incubation system. Supplied as a reusable instrument with sterile disposable consumables, it adheres to FDA 510(k) clearance under regulation 866.1645 and is classified as a Class II device. Storage and handling follow manufacturer guidelines to maintain sterility and performance, with no MRI safety restrictions specified.
Frequently asked questions
What specific types of bacterial infections does this device test for, and how does it help in clinical decision-making?
This device is designed for in vitro susceptibility testing of Gram-negative bacterial pathogens, meaning it evaluates how these bacteria respond to ciprofloxacin—a commonly used antibiotic. By testing resistance patterns, clinicians can determine whether ciprofloxacin is an effective treatment option for infections caused by these bacteria, helping to guide targeted therapy and reduce unnecessary antibiotic use.
Is the BD Phoenix Automated Microbiology System reusable, and what consumables are required for operation?
The system itself is a reusable instrument, but it requires sterile disposable consumables for testing. These consumables include panels and media necessary for running antimicrobial susceptibility tests, ensuring each test is performed under controlled, sterile conditions to maintain accuracy and prevent cross-contamination.
How does the automated nature of this system benefit microbiology laboratories compared to manual testing methods?
The BD Phoenix Automated Microbiology System automates the short-term incubation and detection of antimicrobial resistance, significantly reducing manual labor and human error. This speeds up results while maintaining precision, allowing laboratories to process more samples efficiently and provide faster clinical insights for patient care.
What storage and handling precautions should be taken to ensure the device and its consumables remain effective?
The device and its consumables must be stored and handled according to manufacturer guidelines to preserve sterility and performance. While no MRI safety restrictions are specified, proper environmental controls (e.g., temperature, humidity) and sterile packaging handling are critical to maintaining accuracy and preventing contamination during use.
What regulatory pathway was followed for FDA clearance, and how does this affect its classification?
This device received FDA 510(k) clearance under regulation 866.1645, with a substantially equivalent determination by the Microbiology Advisory Committee. It is classified as a Class II device, meaning it undergoes rigorous review to ensure safety and effectiveness while balancing regulatory oversight with accessibility for clinical use.
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 - GN Ciprofloxacin (0.0156-4 ..., BD Phoenix™ Automated Identification and Susceptibility, BD Phoenix? Automated Microbiology System - GN Ciprofloxacin (0.0156?4 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233986 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K233986 24 fields · synced Oct 6, 2026