510(k) Report

510(k) · Cleared

Cleared

Selux AST System; Model AST Gen 1.0

K211748510(k) TraditionalCleared Apr 19, 2023681-day reviewClass II21 CFR 866.1645

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Selux Diagnostics, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Cleared on Apr 19, 2023 as substantially equivalent to K190905 (Becton, Dickinson and Company, 2019) after a 681-day review. Its family tree reaches back 2 generations to 2014.

Decided
Apr 19, 2023
Review
681 days
Class
Class II
Product code
LON
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K132909 (2014). No later device cites it as a predicate yet.

K132909 · BD Phoenix Automated Microbiology System Tigecycline (0.25-16 UG/ML) · Becton, Dickinson and Company · 2014K190905 · BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL) · Becton, Dickinson and Company · 20192010201520202025
K190905 · BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL) · Becton, Dickinson and Company · 2019K132909 · BD Phoenix Automated Microbiology System Tigecycline (0.25-16 UG/ML) · Becton, Dickinson and Company · 20140
  1. Root · 2 generations backK132909 BD Phoenix Automated Microbiology System Tigecycline (0.25-16 UG/ML)Becton, Dickinson and Company · 2014
  2. 1 generation backK190905 BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4…Becton, Dickinson and Company · 2019
  3. This deviceK211748 Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc. · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K132909BD Phoenix Automated Microbiology System Tigecycline (0.25-16 UG/ML)Becton, Dickinson and Company2014—
−1K190905BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)Becton, Dickinson and Company2019—
0 (this device)K211748Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc.2023—
FIG. 1 — Lineage of K211748, 2014–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LON? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LON device

  1. #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K190905BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
Summary page 6
…BD Phoenix Automated Microbiology System- Ceftaroline 0.0156-4 µg/mL Manufacturer: Becton, Dickinson and Company 510(k) Reference: K190905 Common Name: Antimicrobial Susceptibility Test System Regulation Number: 21 CFR 866.1645 Regulation Name: Fully aut…
Becton, Dickinson and Company2019—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All LON devices

LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · LON

5in 2025

2007: 192008: 72009: 82010: 12011: 82012: 102013: 72014: 42016: 32017: 102018: 42019: 82020: 52021: 52022: 82023: 112024: 22025: 52026 (partial year): 4
2007high 19 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LON

90in 2025

2007: 50 days median2008: 66 days median2009: 76 days median2011: 85 days median2012: 200 days median2013: 115 days median2014: 90 days median2016: 242 days median2017: 89 days median2018: 88 days median2019: 84 days median2020: 81 days median2021: 268 days median2022: 189 days median2023: 210 days median2025: 90 days median2026 (partial year): 146 days median
2007high 268 (2021) · low 50 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LON

1in 2025

2008: 12010: 1162011: 32012: 32014: 2, 2 Class I2016: 22017: 12018: 62019: 12020: 82022: 152024: 12025: 12026 (partial year): 6
2007high 116 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LON

690in 2025

2007: 32008: 12010: 32011: 42012: 92013: 32014: 102015: 412016: 942017: 1972018: 5122019: 3152020: 2182021: 2322022: 1802023: 4532024: 4182025: 690
2007high 690 (2025) · low 0 (2009)2025

MAUDE reports naming product code LON, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007195003
200876611
200987600
20101—1163
201188534
20121020039
2013711503
20144902 (2)10
20150—041
20163242294
201710891197
20184886512
20198841315
20205818218
202152680232
2022818915180
2023112100453
20242—1418
20255901690
202641466—

What is it indicated for?

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…

Read the full statement (484 words)

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)

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Selux Diagnostics, Inc.

4 FDA decisions under this applicant name. See the company

  • K244044PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 2025
  • K223493PBC Separator with Selux AST SystemSelux Diagnostics, Inc. · 2024
  • K211759Selux AST System; Model AST Gen 1.0Selux Diagnostics, Inc. · 2023

Recent decisions in LON

The LON category page

  • K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)bioMerieux, Inc. · 2026
  • K260619VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)Biomérieux, Inc. · 2026
  • K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
  • K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)Biomerieux · 2026
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025

https://510kreport.com/device/K211748 · printed Nov 4, 2026

Cite this page

510(k) Report. “K211748: Selux AST System; Model AST Gen 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211748

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026