# K060444: BD Phoenix Automated Microbiology System - Cefepime (GN) , Ceftriaxone (GN), Cefotaxime (GN), 0.5-64 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Apr 12, 2006 after 50 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020322 (2002). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020321: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.
- K032675: BD Phoenix Automated Microbiology System-Cefepime (GN) 0.5-65 UG/ML, Becton, Dickinson & CO (2004) Summary page 1.
- K032655: BD Phoenix Automated Microbiology System-Ceftriaxone 0.5-64 UG/ML, Becton, Dickinson & CO (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- N005010: VITEK System. Number could not be read

## Most influential descendants
- K063301: BD Phoenix Automated Microbiology System - Cefepime (GN) 0.5-64UG/ML (2006), 0 descendants of its own
- K062944: BD Phoenix Automated Microbiology System - Ceftriaxone (GN) 0.5-64UG/ML (2006), 0 descendants of its own

## Indications for use
The BD PhoenixTM Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus. This premarket notification is for additional organism groups and BD Phoenix Tm Automated Microbiology System with cefepime (0.5-64 gg/mL) and ceftriaxone (0.5-64 p.g/mL) on Gram- negative ID/AST or AST only Phoenix panels. Cefepime has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent. Active In Vitro and in Clinical Infections Against: Enterobacter species Pseudomonas aeruginosa Escherichia coli Klebsiella pneumoniae Active In Vitro Against: Acinetobacter iwoffi Pantoea agglomerans Citrobacter koseri Providencia rettgeri Citrobacter freundii Providencia stuartii Hafnia alvei Serratia marcescens Klebsiella oxytoca Morganella morganii Ceftriaxone has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent. Active In Vitro and in Clinical Infections Against: Acinetobacter calcoaceticus Klebsiella oxytoca Serratia marcescens Enterobacter aerogenes Klebsiella pneumoniae Pseudomonas aeruginosa Enterobacter cloacae Morganella morganii Escherichia coli Proteus mirabilis Active In Vitro Against: Citrobacter koseri (formerly C. diversus) Citrobacter freundii Providencia species (including Providencia rettgeri) Salmonella species Shigella species

Source page: https://510kreport.com/device/K060444
Methodology: https://510kreport.com/methodology