# K043389: BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jan 21, 2005 after 43 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.
3 later devices descend from it; 2 cite it directly.
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.
- 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
- K061327: BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GN) 0.5/0.25-32/16 UG/ML, Ampicillin-Sulbactam (GN) 0. (2006), 2 descendants of its own
- K071623: BD Phoenix Automated Microbiology System, Ampicillin-Sulbactam (GN) 1/0.5-32/16 UG/ML (2007), 0 descendants of its own
- K062680: BD Phoenix Automated Microbiology System - Ticarcillin (GN) 1-128 UG/ML (2006), 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 and Enterococcus. This premarket notification is for the addition of the antimicrobial agent ampicillin-sulbactam at concentrations of 0.5/0.25-32/16 pg/mL to gram-negative ID/AST or AST only Phoenix panels. Ampicillin-sulbactam 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: Beta-lactamase producing strains of Escherichia coli Klebsiella spp. (including K. pneumoniae) Active In Vitro Against: Escherichia coli (Beta-lactamase and non-beta-lactamase producing) Klebsiella species (all known strains are beta-lactamase producing) Morganella morganii Providencia rettgeri Providencia stuartii

Source page: https://510kreport.com/device/K043389
Methodology: https://510kreport.com/methodology