# K061673: BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GP) 0.25/0.12 -32/16 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jul 28, 2006 after 44 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: 2 generations back to K020322 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 1.
- K060324: BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 UG/ML - Gram-Negative, Becton, Dickinson & CO (2006) Summary page 1.
- 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
- P050010: Prodisc -L Total Disc Replacement Device, Centinel Spine, LLC (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The BD 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 Enterobacteriaceaeand Non-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus. This premarket notification is for the addition of the antimicrobial agent amoxicillin-clavUlanate at concentrations of 0.25/0.12-32/16 pg/mL to Gram-positive ID/AST or AST only Phoenix panels. Amoxicillin-clavulanate 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: Staphylococcus aurens (beta-lactamase and non-beta-lactamase producing) Active In Vitro Against: EnIerococcusficicalis S[ap]hylococccus epidermidis (beta-lactamase and non-beta-lactamase producing) Stlaphylococcus saprophyticus (beta-lactamase and non-beta-lactamase producing)

Source page: https://510kreport.com/device/K061673
Methodology: https://510kreport.com/methodology