# K031429: BD Phoenix Automated Microbiology System-Meropenem 0.25-16 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Bd Diagnostic Systems
- Decided: Jun 6, 2003 after 31 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 K020322 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020321: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 3.
- K020323: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.
- K020322: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.

## 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

## Indications for use
The BD Phoenix'M Automated Microbiology System is intended for in vi/ro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Eii/erobacteriaceaeand Non-Ei7ferobacteriuceae and rrEbst Gram-positive bacteria isolates from pure culture belonging to the genera S/c~pI~ylococcus and Eiitcrococciis. This premarket notification is for the addition of the antimicrobial agent nieropenem at concentrations of 0.25-16 pg/mL 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 FEA-approved package insert for this antimicrobial agent. Active I n Vitro and in Clinical Infections Against: Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa Active In Vitro Against: Acinetobacter species Hafnia alvei Salmonella species Aeromonas hydrophila Klebsiella oxytoca Serratia inarcescens Cilrobacter koseri Morganella morganii Shigella species Citrobacter .fie irndii Proteus mirabilis Yersinin enlerocolitica Enterobacter cloacae Proteus vulgaris

Source page: https://510kreport.com/device/K031429
Methodology: https://510kreport.com/methodology