# K060447: BD Phoenix Automated Microbiology System -Nitrofurantoin (GN) 8-512 UG/ML, Trimethoprim-Sulfamethoxazole (GN)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Apr 26, 2006 after 64 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: 2 generations back to K020322 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 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.
- K031530: BD Phoenix Automated Microbiology System-Nitrofurantoin-8-512 UG/ML, Becton, Dickinson & CO (2003) Summary page 1.
- K033907: BD Phoenix Automated Microbiology System - Trimethoprim-Sulfamethoxazole 0.5/9.5 - 16/304 UG/ML, Becton, Dickinson & CO (2004) Summary page 1.
- K030579: BD Phoenix Automated Microbiology System-Nalidixic Acid - 2-32 UG/ML, Becton, Dickinson & CO (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- N50510: Vitek Systems General Susceptibility Card, Biomerieux Vitek, Inc. (1978). Number could not be read Summary page 1.

## 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 Enterobacteriaceaeand Non-Enterobacteriaceaeand most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus. This premarket notification is for additional organism groups and BD PhoenixTM Automated. Microbiology System with Nitrofurantoin (8-512 gg/mL), Trimethoprim-sulfamethoxazole (0.5/9.5-16/304 fig/ mL) and Nalidixic Acid (2-32gg/mL) on Gram-negative lD/AST or AST only Phoenix panels. Nitrofurantoin 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: Escherichiacoli Active In Vitro Against: Citrobacteramalonaticus Citrobacterkoseri (diversus) Citrobacterfreundii Klebsiella oxytoca Klebsiellapneumoniae (ozaenae) Trimethoprim-sulfamethoxazole 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: Escherichiacoli Proteus mirabilis Klebsiella species Proteusvulgaris Enterobacter species Shigellaflexneri Morganella morganii Shigella sonnei Nalidixic Acid 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: Enterobacter species Morganella morganii Proteus vulgaris Escherichiacoli Proteusmirabilis Providenciarettgeri

Source page: https://510kreport.com/device/K060447
Methodology: https://510kreport.com/methodology