# K060324: BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 UG/ML - Gram-Negative

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: May 25, 2006 after 105 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.
11 later devices descend from it; 10 cite it directly.
0 of 15 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

## Most influential descendants
- K061867: BD Phoenix Automated Microbiology System-Cefazolin (GN) 0.5-32 UG/ML (2006), 1 descendant of its own
- K082852: BD Phoenix Automated Microbiology System-Nitrofurantoin (GP) 4-128 UG/ML (2009), 0 descendants of its own
- K082913: BD Phoenix Automated Microbiology System-Doxycycline (GP) 0.25-16 UG/ML (2008), 0 descendants of its own
- K082538: BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance Test (2008), 0 descendants of its own
- K073589: BD Phoenix Automated Microbiology System-Daptomycin (0.0313-16 UG/ML) Steptococcus ID/Ast or Ast Only Phoenix Panels (2008), 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 Gram-negative organism groups and Gatifloxacin (0.25-8 itg/mL) on the BD Phoenix Automated Microbiology System. Gatifloxacin 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: Active In Vitro Against: Aerobic Gram-negative microorganisms Aerobic Gram-negative microorganisms Escherdchin coi Acinetobacter Iwoff1i Klebsiella pneumoniae Citrobecter kosed Proteus mirabilis Citrobacterfreundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganellsmorganii Proteus vulgaris Results for Enterobacteriaceaetested with Gatifloxacin should only be reported for isolates recovered from the urinary tract.

Source page: https://510kreport.com/device/K060324
Methodology: https://510kreport.com/methodology