# K132674: BD Phoenix Automated Microbiology System- Meropenem (0.125-32 UG/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Dec 27, 2013 after 122 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 1 (0 Class I)
- 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
- P050510: VITEK®i 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

## Recalls of this device
- Feb 29, 2024 · Class II · Z-1398-2024: Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results

## Indications for use
The BD Phoenixm 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 Enterobacteriacean 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 meropenemn at concentrations of 0.125-32 pglmL to Gram-negative ID/AST or AST only Phoenix panels. Meropenem 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 171o and In Clinical Infections Against: Eseherichia coil Kiebsiella pneumoniae Pseudomonas aeruginosa Active In Vftro Citrobacter koseri (formerly di vers us) Morganella morgani Cit robacter freundi Proteus vulgaris Eni'erobacter cloacae Serratia marcescens Kiebsiella oxytoca

Source page: https://510kreport.com/device/K132674
Methodology: https://510kreport.com/methodology