# K251713: BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Aug 8, 2025 after 66 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 K132909 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132909: BD Phoenix Automated Microbiology System Tigecycline (0.25-16 UG/ML), Becton, Dickinson and Company (2014) Summary page 9.

## 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 Enterobacterales and Non-Enterobacterales and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus. This premarket notification is for the BD Phoenix Automated Microbiology System with Eravacycline at a concentration of 0.125-2 µg/mL. Testing is indicated for Enterobacterales as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) has demonstrated acceptable performance with the following organisms: Enterobacterales (Citrobacter amalonaticus, Citrobacter braakii, Citrobacter farmeri, Citrobacter freundii, Citrobacter koseri, Citrobacter youngae, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, and Klebsiella pneumoniae)

Source page: https://510kreport.com/device/K251713
Methodology: https://510kreport.com/methodology