# K163637: BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson & Company
- Decided: Mar 21, 2017 after 88 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: 7 generations back to K032788 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121546: Vitek 2 Gram Negative Doxycycline, bioMerieux, Inc. (2012) Summary page 5.

## 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, Enterococcus and Streptococcus. Ceftazidime/avibactam 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 Citrobacter freundii complex Citrobacter koseri Escherichia coli Enterobacter aerogenes Enterobacter cloacae Klebsiella pneumoniae Klebsiella oxytoca Proteus spp. Pseudomonas aeruginosa Active In Vitro but clinical significance is unknown Morganella morganii Providencia stuartii Serratia marcescens

Source page: https://510kreport.com/device/K163637
Methodology: https://510kreport.com/methodology