# K063301: BD Phoenix Automated Microbiology System - Cefepime (GN) 0.5-64UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Dec 8, 2006 after 37 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: 3 generations back to K020322 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K020323: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.
- K020322: 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 3.
- K060444: BD Phoenix Automated Microbiology System - Cefepime (GN) , Ceftriaxone (GN), Cefotaxime (GN), 0.5-64 UG/ML, Becton, Dickinson & CO (2006) Summary page 3.

## Cited in the summary but kept off the family tree
- P050510: VITEK System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## 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 Enterobacteriaceac 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 cefepime at concentrations of 0.5-64 ig/mnL to Gram-negative ID/AST or AST only Phoenix panels with the removal of the limitations for Proteus species. 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 Proteus mirabilis Escherichia coli Pseudomonas aeruginosa Klebsiella pneumoniae Active In Vitro A2ainst: Acinetobacter lwoffi Klebsiella oxytoca Providencia rettgeri Citrobacter koseri Morganella morganii Providencia stuartii Citrobacter freundii Pantoea agglomerans Serratia marcescens Hafnia alvei Proteus vulgaris

Source page: https://510kreport.com/device/K063301
Methodology: https://510kreport.com/methodology