# K060218: BD Phoenix Automated Microbiology System - Erythromycin-0.0625-8 UG/ML, and Quinupristin/Dalfopristin-0.25-4 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Mar 17, 2006 after 49 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.
- K033784: BD Phoenix Automated Microbiology System - Erythromycin 0.0625-8 UG/ML, Becton, Dickinson & CO (2004) Summary page 1.
- K022172: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.
- K033889: BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Chloramphenicol 1-32 UG/ML Gram Positive, Becton, Dickinson & CO (2004) 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 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 additional organism groups and BD Phoenix TM Automated Microbiology System with erythromycin (0.0625-8 pg/mL), quinupristin/dalfopristin (0.25-4 gg/mL), and chloramphenicol (1-32 pg/mL) on ID/AST or AST only Phoenix panels. Erythromycin 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 Quinupristin/dalfopristin 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: Aerobic Gram-positive microorganisms Enterococcus faecium (vancomycin-resistant and multi-drug resistant strains only) Staphylococcus aureus (methicillin-susceptible strains only) Active In Vitro Against: Aerobic Gram-positive microorganisms Staphylococcus aureus (methicillin-resistant strains) Staphylococcus epidermidis (including methicillin-resistant strains) Synercid is not active against Enterococcus faecalis. Differentiation of enterococcal species is important to avoid misidentification of Enterococcus faecalis as Enterococcus faecium. Chloramphenicol 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

Source page: https://510kreport.com/device/K060218
Methodology: https://510kreport.com/methodology