# K244044: PBC Separator with Selux AST System

- Pathway: 510(k) (Traditional)
- Applicant: Selux Diagnostics, Inc.
- Decided: Mar 28, 2025 after 88 days
- Product code: QZX (Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing)
- Device class: 2
- Regulation: 21 CFR 866.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN160032 (2017). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223493: PBC Separator with Selux AST System, Selux Diagnostics, Inc. (2024) Summary page 6.

## Indications for use
The PBC Separator with Selux AST System is an automated inoculum preparation system that uses lysis, centrifugation and sequential optical density measurements to generate a McFarland-equivalent suspension from positive blood culture samples that can be used for quantitative in vitro antimicrobial susceptibility testing by the Selux AST System. Samples are processed directly from blood culture samples identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial, gram negative rods or gram positive cocci by Gram stain. Organism identification is required for AST result interpretation and reporting, per the Selux AST System Instructions for Use. Inoculum preparation by the PBC Separator was evaluated for use with the Selux AST System and the Selux AST Gram Negative Panel. Performance was demonstrated for the antimicrobial agents and organisms identified below: » Amikacin: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa » Amoxicillin-Clavulanate: Escherichia coli, Klebsiella species (including K. oxytoca, K. pneumoniae), Proteus mirabilis, Proteus vulgaris » Ampicillin: Escherichia coli, Proteus mirabilis » Ampicillin-Sulbactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis * 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, Pseudomonas aeruginosa » Ceftazidime: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa * Ceftazidime-Avibactam: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa * Ceftriaxone: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens * Ciprofloxacin: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa * Ertapenem: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens * Gentamicin: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa * Imipenem: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae » Meropenem: Acinetobacter baumannii complex, Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa » Minocycline: Acinetobacter baumannii complex, Escherichia coli, Klebsiella pneumoniae * Piperacillin-Tazobactam: Acinetobacter baumannii complex, Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Pseudomonas aeruginosa » Tobramycin: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa Inoculum preparation by the PBC Separator was evaluated for use with the Selux AST System and the Selux AST Gram Positive Panel. Performance was demonstrated for the antimicrobial agents and organisms identified below: » Ampicillin: Enterococcus faecalis, Enterococcus faecium * Ceftaroline: Staphylococcus aureus * Daptomycin: Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus * Linezolid: Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus * Oxacillin: Staphylococcus aureus * Vancomycin: Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus The PBC Separator with Selux AST System 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 Susceptibility test results are intended to be used in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing as needed. Additionally, subculture of positive blood culture is necessary for the susceptibility testing of organisms present in polymicrobial samples, for testing antimicrobial agents and species not indicated for testing with the device, for epidemiologic testing, and for recovery of organisms present in microbial samples.

Source page: https://510kreport.com/device/K244044
Methodology: https://510kreport.com/methodology