Bd Phoenix Automated Microbiology System - Cefepime (Gn), Ceftriaxone (Gn), Cefotaxime (Gn), 0.5-64 Ug/Ml
by Becton, Dickinson & CO 510(k)
Active
510(k) K060444
Overview
The BD Phoenix Automated Microbiology System is an automated system used for antimicrobial susceptibility testing. It is designed to determine the susceptibility of most Gram-negative bacteria to antibiotics at concentrations ranging from 0.5 to 64 µg/mL. The system specifically tests cefepime, ceftriaxone, and cefotaxime antibiotics.
This device is intended for use in clinical laboratories as an in vitro test. It is supplied as part of the Phoenix™ Gram Negative ID/AST and AST only panel. The device is regulated under FDA 510(k) clearance with product code LON and is classified as a Class II device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060444 | Date12 Apr 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LON
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1645
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Becton, Dickinson & Co.
Questions
What is the BD Phoenix Automated Microbiology System used for?
The BD Phoenix Automated Microbiology System is designed for antimicrobial susceptibility testing, specifically determining the susceptibility of most Gram-negative bacteria to antibiotics including cefepime, ceftriaxone, and cefotaxime at concentrations ranging from 0.5 to 64 µg/mL.
How is the BD Phoenix system supplied?
The device is supplied as part of the Phoenix™ Gram Negative ID/AST and AST only panel, intended for use in clinical laboratories as an in vitro test to identify bacterial susceptibility patterns.
What is the regulatory classification of the BD Phoenix system?
The BD Phoenix Automated Microbiology System is regulated under FDA 510(k) clearance with product code LON and is classified as a Class II device, indicating it has special controls to ensure its safety and effectiveness.
What antibiotics does the BD Phoenix system test for?
The system specifically tests for susceptibility to cefepime, ceftriaxone, and cefotaxime antibiotics, providing clinical laboratories with critical data for appropriate antibiotic selection in treating Gram-negative bacterial infections.