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BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K190905

by Becton, Dickinson and Company

Identifiers

510(k) Number
K190905 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 Ceftaroline (0.0156–4 µg/mL) is an automated antimicrobial susceptibility testing system designed for gram-negative (GN) bacteria. It performs rapid identification and antibiotic susceptibility testing, enabling precise determination of bacterial resistance profiles to ceftaroline within a defined concentration range.

This system is intended for use in clinical microbiology laboratories and operates as a reusable, automated instrument. It is classified under FDA regulation 866.1645 as a Class II device, with clearance granted under the 510(k) pathway as substantially equivalent to a predicate device. The system requires proper calibration, maintenance, and adherence to manufacturer instructions for accurate and reliable performance.

Frequently asked questions

What specific type of bacteria is the BD Phoenix Automated Microbiology System – GN Ceftaroline designed to test for, and what does it measure?

This system is specifically designed for gram-negative (GN) bacteria and performs antimicrobial susceptibility testing for ceftaroline within a concentration range of 0.0156–4 µg/mL. It helps determine whether bacterial isolates are resistant or susceptible to ceftaroline, enabling precise resistance profiling for clinical decision-making.

Is the BD Phoenix Automated Microbiology System reusable, and what maintenance is required to ensure accurate results?

Yes, the system is reusable and designed as an automated instrument for clinical microbiology laboratories. To maintain accuracy and reliability, it requires proper calibration, regular maintenance, and strict adherence to the manufacturer’s instructions—as outlined in the device’s operational guidelines.

How was the regulatory pathway for this device determined, and what does that mean for its use in clinical settings?

The device was cleared via the FDA 510(k) pathway, classified as substantially equivalent (SESE) to a predicate device under regulation 866.1645. This means it underwent a review by the Microbiology (MI) Advisory Committee to confirm it performs similarly to an existing approved system, ensuring its safety and effectiveness for antimicrobial susceptibility testing in clinical microbiology labs.

What kind of clinical environment is this system intended for, and does it require specialized training to operate?

The system is intended for use in clinical microbiology laboratories, where trained personnel perform bacterial identification and antibiotic resistance testing. While the device itself is automated, proper training in calibration, maintenance, and interpretation of results is essential to ensure accurate and reliable performance, as specified by the manufacturer.

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 Ceftaroline (0.0156-4 µg ..., BD Phoenix Automated Microbiology System - GN Ceftaroline (0.0156-4 µg ..., PDF K190905 BD Phoenix Automated Microbiology System - GN Ceftaroline (0. ...

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) K190905 24 fields · synced Sep 18, 2026