# K031589: BD Phoenix Automated Microbiology System-Nitrofurantoin Gram Positive

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jul 11, 2003 after 51 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.

## 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.

## Most influential descendants
- K082852: BD Phoenix Automated Microbiology System-Nitrofurantoin (GP) 4-128 UG/ML (2009), 0 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 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 nitrofurantoin at concentrations of 16-512 pg/mL to Gram Positive ID/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: Staphylococcus aureus Enterococcus faecalis Active In Vitro Against: Staphylococcus species

Source page: https://510kreport.com/device/K031589
Methodology: https://510kreport.com/methodology