# K033558: BD Phoenix Automated Microbiology System - Aztreonam 0.5-64 UG/ML-Gram-Negative ID/Ast or Ast Only Phoenix Panels

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Dec 19, 2003 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: 1 generation back to K020322 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- 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.
- (no number) VITEK® System: named in the summary without a submission number

## Most influential descendants
- K063824: BD Phoenix Automated Microbiology System - Aztreonam (GN) 0.5-64UG/ML (2007), 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 and Enterococcus. This premarket notification is for the addition of the antimicrobial agent aztreonam at concentrations of 0.5-64 μg/mL to gram-negative ID/AST or AST only Phoenix panels. Aztreonam 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: Citrobacter species (including C. freundii) Klebsiella pneumoniae Enterobacter species (including E. cloacae) Proteus mirabilis Escherichia coli Serratia species (including S. marcescens) Klebsiella oxytoca Active In Vitro Against: Aeromonas hydrophila Providencia stuartii Morganella morganii Providencia rettgeri Pasteurella multocida Yersinia enterocolitica Proteus vulgaris

Source page: https://510kreport.com/device/K033558
Methodology: https://510kreport.com/methodology