# K020322: BD Phoenix Automated Microbiology System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Mar 27, 2002 after 71 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
No predicates in its family tree.
118 later devices descend from it; 94 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## 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
- K060324: BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 UG/ML - Gram-Negative (2006), 11 descendants of its own
- K023301: BD Phoenix Automated Microbiology System (2002), 10 descendants of its own
- K071026: BD Geneohm Staphsr Assay (2007), 9 descendants of its own
- K082140: Xpert Mrsa/SA Blood Culture Assay (2008), 3 descendants of its own
- K043389: BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/ML (2005), 3 descendants of its own

## Indications for use
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture belonging to the family Enterobacteriaceae and most glucose nonfermenting gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus. This premarket notification is for the addition of the antimicrobial Levofloxacin at concentrations of 0.25-8 pg to Gram negative and Gram positive ID/AST or AST only Phoenix panels. Levofloxacin 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 antimicrobic. Active In Vitro and in Clinical Infections Against: Active In Vitro Against: Aerobic Gram-positive microorganisms Aerobic Gram-positive microorganisms Staphylococcus epidermidis (methicillin susceptible strains) Enterococcus faecalis (many strains are moderately susceptible) Staphylococcus aureus (methicillin-susceptible strains) Staphylococcus saprophyticus Aerobic Gram-negative microorganisms Acinetobacter baumannii Aerobic Gram-negative microorganisms Acinetobacter lwoffii Enterobacter cloacae Citrobacter koseri Escherichia coli Citrobacter freundii Klebsiella pneumoniae Enterobacter aerogenes Proteus mirabilis Enterobacter sakazakii Pseudomonas aeruginosa Klebsiella oxytoca Morganella morganii Pantoea agglomerans Proteus vulgaris Providencia retigeri Providencia stuartii Pseudomonas fluorescens Serratia marcescens Results for Pseudomonas aeruginosa, other Non-Enterobacteriaceae and Enterococcus spp. tested with Levofloxacin should only be reported for isolates recovered from the urinary tract.

Source page: https://510kreport.com/device/K020322
Methodology: https://510kreport.com/methodology