# K061327: BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GN) 0.5/0.25-32/16 UG/ML, Ampicillin-Sulbactam (GN) 0.

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jul 3, 2006 after 52 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). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 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.
- K031912: BD Phoenix Automated Micrbiology System Amoxicillin/Clavualante 0.5/0.25-32/16 UG/ML, Becton, Dickinson & CO (2003) Summary page 1.
- K043389: BD Phoenix Automated Microbiology System -Ampicillin-Sulbactam (GN) 0.5/0.25-32/16UG/ML, Becton, Dickinson & CO (2005) Summary page 3.
- K031984: BD Phoenix Automated Microbiology System-Ticarcillin-1-128 UG/ML, Becton, Dickinson & CO (2003) Summary page 2.
- (no number) VITEK® System (PMA No. N505 10): named in the summary without a submission number

## Most influential descendants
- K071623: BD Phoenix Automated Microbiology System, Ampicillin-Sulbactam (GN) 1/0.5-32/16 UG/ML (2007), 0 descendants of its own
- K062680: BD Phoenix Automated Microbiology System - Ticarcillin (GN) 1-128 UG/ML (2006), 0 descendants of its own

## 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-Enterobacteriaceaeand most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus. This premarket notification is for additional organism groups and Amoxicillin-clavulanate (0.5/0.25 - 32/16 Vg/mL), Ampicillin-sulbactam (0.5/0.25-32/16 pg/mL), and Ticarcillin (1-128 ug/mL), on the BD Phoenix Automated Microbiology System. 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: Enterobacterspecies Escherichiacol/i Kiebsiella species Active In Vitro Against: Proteus mirabilis Ampicillin-sulbactam 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: Beta-lactamase producing strains of. Escherichia co/i Klethicl/u spp. (incholing K. pemunoniae) Active In VitroAgainst: Eselhcrichic co/i (Bcta-lactainase and non-beta-htctaamasc piodueing) KNchsiclhi species (all known strains are beta-lactamasc producing , .torgruanella norgimii Providenc[e] W sirl)ii Ticarcillin 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 A2ainst: Pseudonionasaeruginosa (and other species) Escherichia coli Proteus mirabilis Morganella morganil Providencia rettgeri Enterobacterspecies Salmonella species

Source page: https://510kreport.com/device/K061327
Methodology: https://510kreport.com/methodology