# K022172: BD Phoenix Automated Microbiology System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Aug 12, 2002 after 40 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
- P050510: VITEKO 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
- K060218: BD Phoenix Automated Microbiology System - Erythromycin-0.0625-8 UG/ML, and Quinupristin/Dalfopristin-0.25-4 UG/ML (2006), 0 descendants of its own

## Indications for use
The BD PhoenixTMAutomated 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 Eiiterococcus. This premarket notification is for the addition of the antimicrobial agent quinupristiddalfopristin at concentrations of 0.25-4 pg/nL to Gram Positive ID/AST or AST only Phoenix panels. Quinupristiddalfopristin 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 Eitterococcusfaecalis. Differentiation of enterococcal species is important to avoid misidentification of Enterococcusfaecalis as Enterococcusfaeciurn.

Source page: https://510kreport.com/device/K022172
Methodology: https://510kreport.com/methodology