# K140468: BD Phoenix Automated Microbiology System - Ceftaroline (0.625-4 UG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jun 2, 2014 after 97 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P050010: Prodisc -L Total Disc Replacement Device, Centinel Spine, LLC (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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 ceftaroline at concentrations of 0.0625-4 μg/ml to Gram-positive ID/AST or AST only Phoenix panels. Ceftaroline has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package inserts for this antimicrobial agent. Active In Vitro and in Clinical Infections Against: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)

Source page: https://510kreport.com/device/K140468
Methodology: https://510kreport.com/methodology