BD Phoenix Automated Microbiology System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250344 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 is an automated microbiology instrument designed for the identification and antimicrobial susceptibility testing of clinical isolates. It employs short incubation times to deliver rapid and accurate results, supporting evidence-based antimicrobial therapy decisions in microbiology laboratories.
This system is intended for use in clinical microbiology settings and is supplied as a reusable medical device. It operates under FDA 510(k) clearance (K250344) and falls under classification 2 (866.1645) for automated antimicrobial susceptibility testing. The device is not single-use and requires proper maintenance and calibration as specified by the manufacturer.
Frequently asked questions
What clinical setting is the BD Phoenix Automated Microbiology System designed for and what does it primarily do?
The BD Phoenix Automated Microbiology System is designed for clinical microbiology laboratories. It is specifically intended for identifying clinical isolates and performing antimicrobial susceptibility testing, which helps laboratories deliver rapid and accurate results to support evidence-based antimicrobial therapy decisions. The system’s short incubation times accelerate turnaround, making it ideal for fast-paced diagnostic environments.
Is the BD Phoenix Automated Microbiology System a single-use or reusable device, and what maintenance does it require?
The BD Phoenix Automated Microbiology System is a reusable medical device, not intended for single-use. Since it is not disposable, it requires proper maintenance and calibration as outlined by the manufacturer to ensure accurate and reliable performance over time. Regular upkeep is essential for sustaining its functionality in automated antimicrobial susceptibility testing.
How was the regulatory pathway for this device determined, and what classification does it fall under?
The BD Phoenix Automated Microbiology System was cleared through the FDA’s 510(k) pathway, specifically under a *Special* clearance type with a decision labeled *Substantially Equivalent*. It falls under FDA classification 2 (866.1645), which applies to automated antimicrobial susceptibility testing systems. This classification reflects its role in microbiology and its intended use in evidence-based antimicrobial therapy decisions.
What types of clinical isolates can this system identify, and how does its short incubation time benefit laboratories?
While the device is not limited to specific isolate types, the BD Phoenix Automated Microbiology System is designed to identify a broad range of clinical isolates commonly encountered in microbiology labs. Its short incubation times reduce the time required for antimicrobial susceptibility testing, enabling faster results and quicker clinical decision-making—critical for optimizing patient care and reducing unnecessary antibiotic 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™ M50 Automated Microbiology System, BD Phoenix™ Automated Microbiology System (K250344) — FDA 510(k ..., BD (company) - Wikipedia, BD Phoenix? Automated Microbiology System 510(k)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250344 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K250344 24 fields · synced Oct 6, 2026