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BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250447

by Becton, Dickinson and Company

Identifiers

510(k) Number
K250447 FDA 510(k)
FDA Product Code
LON FDA 510(k)
Models / Variants
0.0625 FDA 510(k)
4 - 16 FDA 510(k)
4 µg FDA 510(k)
mL 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 Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) is an automated antimicrobial susceptibility testing system designed for short-incubation microbiological analysis. It identifies bacterial susceptibility to imipenem-relebactam, a combination antibiotic, for Gram-negative organisms including Acinetobacter calcoaceticus-baumannii complex, Enterobacterales, and Pseudomonas aeruginosa.

This system is intended for use in clinical microbiology laboratories and operates as a reusable, non-sterile instrument. It requires compatible consumables and adheres to FDA-recognized susceptibility test interpretive criteria. The device is classified under FDA regulation 866.1645 as a Class II medical device, with a 510(k) clearance (K250447) under the Traditional 510(k) review pathway, granted on May 19, 2025.

Frequently asked questions

What types of bacteria does the BD Phoenix Automated Microbiology System test for susceptibility to imipenem-relebactam?

This system specifically tests Gram-negative bacteria, including *Acinetobacter calcoaceticus-baumannii* complex, Enterobacterales, and *Pseudomonas aeruginosa*. It is designed to determine how these organisms respond to imipenem-relebactam, a combination antibiotic, using a short-incubation method for faster results.

Is the BD Phoenix Automated Microbiology System itself single-use or reusable, and how does that affect its consumables?

The BD Phoenix Automated Microbiology System is a reusable, non-sterile instrument. To operate, it requires compatible consumables that are designed for single-use, ensuring each test run is performed with fresh materials for accuracy and safety.

What is the intended clinical setting for use of this device, and what kind of laboratory staff would typically operate it?

This device is intended for use in clinical microbiology laboratories, where trained laboratory personnel—such as microbiologists, laboratory technicians, or clinical laboratory scientists—would operate it. It is designed to streamline antimicrobial susceptibility testing for Gram-negative bacteria.

How does the BD Phoenix Automated Microbiology System determine if a bacterium is susceptible to imipenem-relebactam?

The system uses automated antimicrobial susceptibility testing with a short-incubation method to evaluate bacterial response to imipenem-relebactam at specific concentrations (ranging from 0.0625/4 to 16/4 µg/mL). It adheres to FDA-recognized interpretive criteria to classify organisms as susceptible or resistant, providing actionable results for treatment decisions.

What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use?

The BD Phoenix Automated Microbiology System received FDA clearance through the Traditional 510(k) review pathway, classified under regulation 866.1645 as a Class II device. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and performance standards for clinical microbiology laboratories.

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 Imipenem-relebactam (0. ..., BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0. ..., BD Phoenix Microbiology System (K250447) | Medical Device Navigator

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K250447 24 fields · synced Sep 18, 2026