# K060558: BD Phoenix Automated Microbiology System Cephalothin - GN 1 - 64 UG/ML

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: May 11, 2006 after 70 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.
- 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.
- K031943: BD Phoenix Automated Microbiology System - Cephalothin (GN) 1-64 UG/ML, Becton, Dickinson & CO (2003) 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 PhoenixMT 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 Gram-negative organism groups and Cephalothin (1-64 gg/mL) on the BD Phoenix Automated Microbiology System. Cephalothin has been shown to be active in vitro against most strains of microorganisms listed below. Because the drug insert for cephalothin (CF) was unavailable, the organisms that were included are those organisms listed in other sources such as "The Sanford Guide to Antimicrobial Therapy" for 1st generation cephalosporins and/or those organisms listed in the drug inserts for those drugs for which cephalothin is considered the predictor of activity per the CLSI M100-S15, Table 2C. Active In Vitro and in Clinical Infections Against: Escherichia coli Klebsiella pneumioniae Proteus mirabilis

Source page: https://510kreport.com/device/K060558
Methodology: https://510kreport.com/methodology