# K062680: BD Phoenix Automated Microbiology System - Ticarcillin (GN) 1-128 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Oct 5, 2006 after 27 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: 3 generations back to K020322 (2002). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K031984: BD Phoenix Automated Microbiology System-Ticarcillin-1-128 UG/ML, Becton, Dickinson & CO (2003) Summary page 1.
- K061327: BD Phoenix Automated Microbiology System-Amoxicillin-Clavulanate (GN) 0.5/0.25-32/16 UG/ML, Ampicillin-Sulbactam (GN) 0., Becton, Dickinson & CO (2006) 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™ 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 ticarcillin for the removal of the limitation for Proteus vulgaris/penneri from the original premarket notification (K031984, August 27, 2003) and subsequent premarket notification (K061327, July 3, 2006). 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 Clinical Infections Against: Escherichia coli Proteus species (both indole-positive and indole-negative) Enterobacter species Pseudomonas aeruginosa Active In Vitro Against: Enterobacter species Proteus vulgaris Escherichia coli Pseudomonas aeruginosa (and other species) Morganella morganii Providencia rettgeri Proteus mirabilis Salmonella species

Source page: https://510kreport.com/device/K062680
Methodology: https://510kreport.com/methodology