# K023301: BD Phoenix Automated Microbiology System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Nov 12, 2002 after 40 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: 1 generation back to K020322 (2002). 3 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 14 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.

## 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

## Most influential descendants
- K071026: BD Geneohm Staphsr Assay (2007), 9 descendants of its own
- K082140: Xpert Mrsa/SA Blood Culture Assay (2008), 3 descendants of its own
- K101879: Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10 (2010), 2 descendants of its own
- K130894: Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi); Genexpert Infinity-48 System; Gene (2013), 1 descendant of its own
- K102342: Keypath (TM) Mrsa/Mssa Blood Culture Test- BT (2011), 1 descendant of its own

## Recalls of this device
- Jun 1, 2016 · Class III · Z-0312-2017: BD has determined that the PhoenixSpec AP Calibrator referenced in this recall from the following lot (5327782) are labeled with an incorrect expiration date (year). The expiration date printed on the
- Jun 1, 2016 · Class III · Z-0311-2017: BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year). The expiration da

## Indications for use
The BD PhoenixTh' 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-Enrerobacteriaceae and most gram-positive bacteria isolates from pure culture belonging to the genera Sraphylococcus and Enterococcus. This premarket notification is for the addition of the antimicrobial agent Oxacillin at concentrations of 0.0625-4 pg/mL to Gram Positive ID/AST or AST only Phoenix panels. Oxacillin 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: Aerobic Gram-positive microorganisms Staphylococcus spp.

Source page: https://510kreport.com/device/K023301
Methodology: https://510kreport.com/methodology