510(k) · Cleared
ClearedVITEK REVEAL GN AST Assay and VITEK REVEAL AST System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Cleared on Jul 8, 2026 as substantially equivalent to K230675 (Specific Diagnostics, LLC, 2024) after a 169-day review. Its family tree reaches back 2 generations to 2017.
- Decided
- Jul 8, 2026
- Review
- 169 days
- Class
- Class II
- Product code
- SAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN160032 (2017). No later device cites it as a predicate yet.
- Root · 2 generations backDEN160032 Accelerate Pheno system, Accelerate Phenotest BC KitAccelerate Diagnotics · 2017
- 1 generation backK230675 VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, LLC · 2024
- This deviceK260160 VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN160032 | Accelerate Pheno system, Accelerate Phenotest BC Kit | Accelerate Diagnotics | 2017 | — |
| −1 | K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | Specific Diagnostics, LLC | 2024 | — |
| 0 (this device) | K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. | 2026 | — |
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 SAN? 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 SAN device
- #1 K211815 LifeScale Gram Negative Kit (LSGN) with the…score 13.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSummary page 7…REVEALTM AST System C. Predicate Device: VITEK® REVEAL™ GN AST Assay and VITEK® REVEALTM AST System (K230675) D. Device Description: The VITEK® REVEAL™ AST System detects bacterial growth using an array of proprietary chemical Small Mole… | 2024 |
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 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All SAN devicesSAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SAN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SAN
577in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SAN
No recall names SAN since 2007.
Adverse event reports per year · SAN
No MAUDE report names SAN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 4 | 577 | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 169 | 0 | — |
What is it indicated for?
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…
Read the full statement (740 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260160 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260160: VITEK REVEAL GN AST Assay and VITEK REVEAL AST System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260160
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026