# K082538: BD Phoenix Automated Microbiology System-Phoenix Inducible Macrolide Resistance Test

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Nov 20, 2008 after 79 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 1 (0 Class I)
- 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)
- K073653: Sensititre 18 - 24 Hour Susceptibility Plate, Trek Diagnostic Systems, Inc. (2008) Summary page 1.
- K020321: BD Phoenix Automated Microbiology System, Becton, Dickinson & CO (2002) Summary page 1.
- K060324: BD Phoenix Automated Microbiology System for Use with the Antimicrobial Agent Gatifloxacin 0.25-8 UG/ML - Gram-Negative, Becton, Dickinson & CO (2006) 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.

## Recalls of this device
- May 11, 2017 · Class II · Z-0171-2018: BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb) test contained on lot 7031818 of Phoenix panels. Th

## 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 the addition of the Phoenix Inducible Macrolide Resistance (iMLSb) Test in Staphylococcus species to Gram-positive ID/AST or AST only Phoenix panels. The Phoenix Inducible Macrolide Resistance Test is used to detect inducible macrolide-lincosamide-streptogramin B resistance in Staphylococcus species.

Source page: https://510kreport.com/device/K082538
Methodology: https://510kreport.com/methodology