# K031679: BD Phonenix Automated Microbiology System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jul 16, 2003 after 47 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.
- (no number) VITEK System (PMA No. N505 10): named in the summary without a submission number

## Indications for use
The BD Phoenixm Automated Microbiology System is intended for in vitro quantitative determinaiion 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-Enterobacten'aceae 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 agents gentamicin synergy at a concentration of 500 pg/mL and streptomycin synergy at a concentration of 1000 pg/mL to Gram Positive ID/AST or AST only Phoenix panels. Gentamicin synergy and streptomycin synergy are used to predict synergy between ampicillin, penicillin or vancomycin and an aminoglycoside with enterococci.

Source page: https://510kreport.com/device/K031679
Methodology: https://510kreport.com/methodology