# K131331: BD Phoenix Automated Microbiology System - Vancomycin (0.5-32 UG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jul 10, 2013 after 62 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K250344: BD Phoenix™ Automated Microbiology System (2025), 0 descendants of its own
- K211759: Selux AST System; Model AST Gen 1.0 (2023), 0 descendants of its own

## Recalls of this device
- Sep 23, 2025 · Class II · Z-0239-2026: Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is 
- Oct 31, 2024 · Class II · Z-0592-2025: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are 
- Aug 1, 2024 · Class II · Z-3246-2024: Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections
- Aug 1, 2024 · Class II · Z-3247-2024: Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections

## 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. This premarket notification is for a modification of a portion of the algorithm for Vancomycin (0.5-32 gig/mL) with Enterococcus species and Staphylococcus species and updates for software from the last software cleared by FDA under K040099 through version 6.01. Vancomycin 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: Enterococci (e.g., Enterococcusfaecalis) Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains).

Source page: https://510kreport.com/device/K131331
Methodology: https://510kreport.com/methodology