# K211759: Selux AST System; Model AST Gen 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Selux Diagnostics, Inc.
- Decided: Jan 18, 2023 after 590 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: 1 generation back to K131331 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131331: BD Phoenix Automated Microbiology System - Vancomycin (0.5-32 UG/ML), Becton, Dickinson & CO (2013) Summary page 5.

## Indications for use
Intended Use: The Selux AST System is intended to be used for the automated quantitative or qualitative susceptibility testing for most clinically significant aerobic microorganisms. The Selux AST System does not provide organism identification. Indications for Use: The Selux Gram-Positive Panel is intended for use with the Selux AST System as an in vitro test to determine the susceptibility of isolated colonies of specific Staphylococcus species and Enterococcus species to specific antimicrobial agents when used as instructed. The Selux Gram-Positive Panel is a quantitative test for the following antimicrobial agents with the specific organisms identified below: • Ampicillin: Enterococcus faecium, Enterococcus faecalis • Clindamycin: Staphylococcus aureus, Staphylococcus epidermidis • Ceftaroline: Staphylococcus aureus • Daptomycin: Staphylococcus aureus, Enterococcus faecalis • Delafloxacin: Staphylococcus aureus, Staphylococcus haemolyticus, Enterococcus faecalis • Eravacycline: Staphylococcus aureus, Enterococcus faecalis • Erythromycin: Staphylococcus aureus • Linezolid: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Enterococcus faecium, Enterococcus faecalis • Levofloxacin: Enterococcus faecium, Enterococcus faecalis, methicillin-susceptible Staphylococcus aureus • Minocycline: Staphylococcus aureus • Oxacillin: Staphylococcus aureus, Staphylococcus lugdunensis • Penicillin: Enterococcus faecium, Enterococcus faecalis, Staphylococcus aureus • Trimethoprim: Staphylococcus aureus, Coagulase-Negative Staphylococci (including S. capitus, S. haemolyticus, S. saprophyticus, S. simulans) • Vancomycin: Staphylococcus aureus, Coagulase-Negative Staphylococci (CoNS) (including S. capitus, S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. intermedius group, S. lugdunensis, S. saprophyticus, S. schleiferi, S. simulans) Enterococcus faecium, Enterococcus faecalis The Selux Gram-Positive Panel is a qualitative test for the following antimicrobial agents with the specific target organisms identified below: • Cefoxitin Screen to predict mecA-mediated oxacillin resistance: Staphylococcus aureus, Staphylococcus lugdunensis

Source page: https://510kreport.com/device/K211759
Methodology: https://510kreport.com/methodology