# K050745: BD Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Apr 29, 2005 after 38 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 3 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 4 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

## Recalls of this device
- Dec 20, 2018 · Class II · Z-0934-2019: Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
- Dec 20, 2018 · Class II · Z-0933-2019: Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.
- Dec 20, 2018 · Class II · Z-0935-2019: Panels inoculated using certain lots of the indicator solution are demonstrating an increased occurrence of test aborts.

## 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, Enterococcus and Streptococcus. This premarket notification is for the addition of the antimicrobial agent vancomycin at concentrations of 0.0625-32 ug/mL to the Streptococcus ID/AST or AST only Phoenix panels. Vancomycin 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: Streptococci, including S. pyogenes, S. pneumoniae (including penicillin-resistant strains), S. agalactiae, S. bovis and the viridans group.

Source page: https://510kreport.com/device/K050745
Methodology: https://510kreport.com/methodology