# K020323: BD Phoenix Automated Microbiology System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Apr 4, 2002 after 79 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; 91 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 FDA summary names its predicate without a number.
- (no number) VITEK® System: named in the summary without a submission number

## 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 vifro 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, Non-Enterobacteriaceae and most glucose nonfermenting gram-positive bacteria isolates from pure culture belonging for Staphylococcus and Enterococcus. This premarket notification is for the addition of the antimicrobial Ofloxacin at concentrations of 0.25-8 g to Gram negative and Gram positive ID/AST or AST only Phoenix panels. Ofloxacin 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 aureus Staphylococcus epidermidis (excluding methicillin-resistant strains) Staphylococcus haemolyticus Aerobic Gram-negative microorganisms Staphylococcus saprophyticus Citrobacter koseri (formerly Citrobacter diversus) Enterobacter aerogenes Aerobic Gram-negative microorganisms Escherichia coli Acinetobacter calcoaceticus Klebsiella pneumoniae Aeromonas caviae Proteus mirabilis Aeromonas hydrophila Pseudomonas aeruginosa Citrobacter freundii Enterobacter cloacae Klebsiella oxytoca Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia marcescens Results for Enterobacteriaceae, Pseudomonas aeruginosa and other Non-Enterobacteriaceae tested with Ofloxacin should only be reported for isolates recovered from the urinary tract.

Source page: https://510kreport.com/device/K020323
Methodology: https://510kreport.com/methodology