# K181665: BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Sep 21, 2018 after 88 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: 2 (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)
- K033458: BD Phoenix Automated Microbiology System - Confirmatory Esbl Test, Becton, Dickinson & CO (2004) Summary page 5.
- (no number) BD Phoenix™ Automated Microbiology System – GN: named in the summary without a submission number

## Recalls of this device
- Aug 13, 2026 · Class II · Z-0140-2027: Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.
- Aug 13, 2026 · Class II · Z-0139-2027: Potential for quality control failures with Klebsiella pneumoniae ATCC BAA-1705 when using the CPO Ambler classification feature.

## Indications for use
The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) and quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of Gram Negative aerobic and facultative anaerobic bacteria belonging to the family Enterobacteriaceae and non-Enterobacteriaceae. BD Phoenix CPO detect is a qualitative confirmatory test that uses a growth-based algorithm intended to phenotypically detect carbapenemase-production in Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii on Gram-negative ID/AST or AST only Phoenix panels. The test also provides the Ambler classification (Class A, Class B and Class D) of the carbapenemase produced. One of three test configurations are available per panel for carbapenemase detection with/without Ambler classification for the target organism groups. BD Phoenix CPO detect does not report multiple classes of carbapenemases from a single isolate.

Source page: https://510kreport.com/device/K181665
Methodology: https://510kreport.com/methodology