# K260160: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jul 8, 2026 after 169 days
- Product code: SAN (Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples)
- 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: 2 generations back to DEN160032 (2017). 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)
- K230675: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System, Specific Diagnostics, LLC (2024) Summary page 7.

## Indications for use
The VITEK REVEAL AST System is an automated system that uses an array of sensors to detect volatile organic compounds emitted by growing bacteria for the in vitro quantitative and qualitative determination of antimicrobial susceptibility. Interpretive results (Susceptible/Intermediate/Susceptible-dose dependent/Resistant) are provided for specific drug/organism combinations. 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 and for epidemiologic testing and for recovery of organisms present in microbial samples. The VITEK REVEAL GN AST Assay is indicated for susceptibility testing direct from positive blood culture samples signaled as positive by a continuous monitoring blood culture system and confirmed to contain gram-negative bacilli by Gram stain. This test is performed by laboratory health professionals in a clinical diagnostic setting. Results may be used as an aid to clinicians in determining appropriate antimicrobial therapy. The VITEK REVEAL AST system does not provide organism identification and is not indicated for use with polymicrobial samples. Testing is indicated for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The VITEK REVEAL GN-AST Assay with VITEK REVEAL AST system has demonstrated acceptable performance with the following organisms: Amikacin: Acinetobacter spp. (Acinetobacter baumannii-calcoaceticus complex), Enterobacterales (Citrobacter freundii (including Citrobacter freundii complex), Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Serratia marcescens). Amoxicillin/clavulanate: Enterobacterales (Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis) Ampicillin/sulbactam: Enterobacterales (Escherichia coli, Klebsiella oxytoca, Proteus mirabilis) Aztreonam: Enterobacterales (Citrobacter freundii (including C. freundii complex), Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae (including K. pneumoniae group) and Pseudomonas aeruginosa Cefepime: Enterobacterales (Citrobacter koseri (syn. C. diversus), Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella species (including K. pneumoniae group and K. aerogenes, Klebsiella oxytoca), and Pseudomonas aeruginosa Cefotaxime: Acinetobacter spp. (Acinetobacter baumannii-calcoaceticus complex) and Enterobacterales (Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group) Ceftazidime: Acinetobacter spp. (Acinetobacter baumannii-calcoaceticus complex), Enterobacterales (Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group), and Pseudomonas aeruginosa Ceftazidime/avibactam: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae (including K. pneumoniae group), Proteus mirabilis), and Pseudomonas aeruginosa Ceftolozane/tazobactam: Enterobacterales (Citrobacter koseri, Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Proteus mirabilis, Proteus vulgaris) and Pseudomonas aeruginosa Ceftriaxone: Enterobacterales (Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae (including K. pneumoniae group), and Proteus mirabilis Cefuroxime: Enterobacterales (Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae group, Klebsiella oxytoca, and Proteus mirabilis Ciprofloxacin: Enterobacterales, Citrobacter freundii (including C. freundii complex), Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae (including K. pneumoniae group), Proteus mirabilis, Proteus vulgaris, Serratia marcescens) and Pseudomonas aeruginosa Ertapenem: Enterobacterales (Escherichia coli, Klebsiella pneumoniae (including K. pneumoniae group), Proteus mirabilis, and Proteus vulgaris Gentamicin: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Proteus vulgaris, Serratia marcescens). Imipenem: Acinetobacter spp. (Acinetobacter baumannii-calcoaceticus complex), Enterobacterales (Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group, Serratia marcescens) and Pseudomonas aeruginosa Levofloxacin: Enterobacterales (Citrobacter koseri, Citrobacter freundii (including C. freundii complex), Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae (including K. pneumoniae group), Proteus mirabilis, Proteus vulgaris, Serratia marcescens) and Pseudomonas aeruginosa Meropenem: Acinetobacter spp. (Acinetobacter baumannii-calcoaceticus complex), Enterobacterales (Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella pneumoniae (including K. pneumoniae group), Proteus mirabilis, Proteus vulgaris, Serratia marcescens), and Pseudomonas aeruginosa Meropenem/vaborbactam: Enterobacterales (Citrobacter freundii (incluidng C. freundii complex), Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae (including K. pneumoniae group), Proteus mirabilis) Piperacillin/tazobactam: Enterobacterales (Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae (including K. pneumoniae group), Proteus vulgaris) Tetracycline: Enterobacterales (Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group) Tobramycin: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Serratia marcescens) and Pseudomonas aeruginosa Trimethoprim/sulfamethoxazole: Enterobacterales (Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae group) ESBL Confirmation test: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group

Source page: https://510kreport.com/device/K260160
Methodology: https://510kreport.com/methodology