# K060214: BD Phoenix Automated Mircrobiology System Tetracycline-GN 0.5-16 UG/ML and GP 0.5-16 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Mar 9, 2006 after 41 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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.
- 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.
- K024153: BD Phoenix Automated Microbiology System - Tetracycline - 0.5-16 UG/ML, Becton, Dickinson & CO (2003) Summary page 1.
- K032131: BD Automated Microbiology System Tetracycline - GP 0.5-16 UG/ML-Gram Positive ID/Ast or Ast Only Phoenix Panels, Becton, Dickinson & CO (2003) Summary page 1.
- (no number) VITEK® System (PMA No. N505 10): named in the summary without a submission number

## 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 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 additional organism groups and Tetracycline 0.5-16 ltg/mL on the BD Phoenix Automated Microbiology System. Tetracycline 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: Gram-negative organisms Gram-positive organisms Acinetobacter species Staphylococcus aureus Escherichia coli Enterobacter aerogenes Klebsiella species Shigella species

Source page: https://510kreport.com/device/K060214
Methodology: https://510kreport.com/methodology