# K051204: BD Phoenix Automated Microbiology System Cefepime (Strep) 0.0625-4UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jun 24, 2005 after 44 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: 1 generation back to K020322 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.

## 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 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 cefepime at concentrations of 0.0625-4 jig/mL to Streptococcus 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: Streptococcus pneumoniae Streptococcus pyogenes (Lancefield's Group A streptococci) Viridans group streptococci Active In Vitro Against: Streptococcus agalactiae (Lancefield's Group B streptococci)

Source page: https://510kreport.com/device/K051204
Methodology: https://510kreport.com/methodology