# K132909: BD Phoenix Automated Microbiology System Tigecycline (0.25-16 UG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Feb 14, 2014 after 150 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.
4 later devices descend from it; 3 cite 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)
- 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
- P050510: VITEK® 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
- K190905: BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL) (2019), 1 descendant of its own
- K251713: BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (2025), 0 descendants of its own
- K211748: Selux AST System; Model AST Gen 1.0 (2023), 0 descendants of its own
- K173252: BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) (2018), 0 descendants of its own

## Indications for use
The BID 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 Tigecycline at concentrations of 0.25 - l6pg/mL to Gram-negative ID/AST or AST only Phoenix panels. Tigecycline 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 freundli Kiebsiella oxytoca Enterobacter cloacae Kiebsiella pneumoniae Esoherichia co/i Active In Vitro Serratia marcescens Citrobacter koseri Enterobacter aerogenes

Source page: https://510kreport.com/device/K132909
Methodology: https://510kreport.com/methodology