# K060257: BD Phoenix Automated Microbiology System - Cefoxitin - 0.5-64 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Apr 14, 2006 after 72 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K032567: BD Phoenix Automated Microbiology System-Cefoxitin-Gram Negative, Becton, Dickinson & CO (2003) Summary page 1.
- (no number) VITEK® System (PMA No. N50510): named in the summary without a submission number

## 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 the addition of the antimicrobial agent cefoxitin at concentrations of 0.5-64 jIg/mL to gram-negative ID/AST or AST only Phoenix panels. Cefoxitin 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 Acqainst: Escherichia co/i Proteus mirabilis Klebsie/la spp. (including K. pneumoniae) Proteus vulgaris Morganella morgandi Providenciaspp. (including P. rettgen) Active In Vitro Against: Klebsiella oxytoca

Source page: https://510kreport.com/device/K060257
Methodology: https://510kreport.com/methodology