# K173523: BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Feb 9, 2018 after 87 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BD Phoenix™ Automated Microbiology System – GN Tigecycline (0.25-16 µg/mL): named in the summary without a submission number

## 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. Meropenem-vaborbactam 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 Enterobacter cloacae species complex Escherichia coli Klebsiella pneumoniae Active In Vitro but clinical significance is unknown Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Klebsiella oxytoca Morganella morganii Proteus mirabilis Providencia spp. Serratia marcescens

Source page: https://510kreport.com/device/K173523
Methodology: https://510kreport.com/methodology