# K211748: Selux AST System; Model AST Gen 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Selux Diagnostics, Inc.
- Decided: Apr 19, 2023 after 681 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 K132909 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190905: BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL), Becton, Dickinson and Company (2019) Summary page 6.

## 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-Negative Panel is intended for use with the Selux AST System as an in vitro test to determine the susceptibility of isolated colonies of specific gram-negative bacilli to specific antimicrobial agents when used as instructed. The Selux Gram-Negative Panel is a quantitative test for the following antimicrobial agents with the specific organisms identified below: • Amikacin: Pseudomonas aeruginosa • Amoxicillin-Clavulanate: Escherichia coli, Klebsiella species (including K. oxytoca, K. pneumoniae), Proteus mirabilis • Ampicillin: Escherichia coli, Proteus mirabilis • Ampicillin-Sulbactam: Acinetobacter baumannii complex, Escherichia coli, Klebsiella species (including K. oxytoca, K. pneumoniae), Proteus mirabilis, Proteus vulgaris • Aztreonam: Escherichia coli • Cefazolin: Escherichia coli, Klebsiella pneumoniae • Cefepime: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens • Cefoxitin: Escherichia coli, Klebsiella species (including K. oxytoca, K. pneumoniae), Morganella morganii • Ceftazidime: Citrobacter species (including C. freundii complex, C. koseri), Enterobacter cloacae complex, Escherichia coli, Klebsiella species (including K. aerogenes, K. oxytoca, K. pneumoniae), Proteus mirabilis, Proteus vulgaris, Serratia marcescens • Ceftazidime-Avibactam: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens • Ceftriaxone: Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis • Ciprofloxacin: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa • Eravacycline: Citrobacter freundii complex, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca • Ertapenem: Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens • Gentamicin: Citrobacter species (including C. freundii complex, C. koseri), Enterobacter cloacae complex, Escherichia coli, Klebsiella species (including K. aerogenes, K. oxytoca, K. pneumoniae), Proteus species (including P. mirabilis, P. vulgaris), Pseudomonas aeruginosa, Serratia marcescens • Imipenem-Relebactam: Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Pseudomonas aeruginosa • Levofloxacin: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens • Meropenem: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens • Meropenem-Vaborbactam: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Serratia marcescens • Minocycline: Escherichia coli, Klebsiella species (including K. aerogenes, K. oxytoca, K. pneumoniae) • Piperacillin-Tazobactam: Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris • Tobramycin: Pseudomonas aeruginosa • Trimethoprim-Sulfamethoxazole: Enterobacter cloacae complex, Klebsiella species (including K. aerogenes, K. oxytoca, K. pneumoniae)

Source page: https://510kreport.com/device/K211748
Methodology: https://510kreport.com/methodology