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
Specific Diagnostics, LLC · SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Cleared on Jun 20, 2024 as substantially equivalent to DEN160032 (Accelerate Diagnotics, 2017) after a 468-day review. Its family tree reaches back 1 generation to 2017. 1 later device descends from it.
- Decided
- Jun 20, 2024
- Review
- 468 days
- Class
- Class II
- Product code
- SAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160032 (2017). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN160032 Accelerate Pheno system, Accelerate Phenotest BC KitAccelerate Diagnotics · 2017
- This deviceK230675 VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, LLC · 2024
- Descendant · cites it directly · 0 of its ownK260160 VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160032 | Accelerate Pheno system, Accelerate Phenotest BC Kit | Accelerate Diagnotics | 2017 | — |
| 0 (this device) | K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | Specific Diagnostics, LLC | 2024 | — |
| +1 | K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | bioMerieux, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 |
|---|---|---|---|
| * | DEN160032 | Accelerate Pheno system, Accelerate Phenotest BC KitSummary page 6…egulation Number: 866.1650 Product Code: SAN (primary), LON Predicate Device: Accelerate Pheno System, Accelerate PhenoTest BC Kit, DEN160032, Product Code: PRH, NSU, LON, PEO, PEN, PAM VITEK® REVEAL™ AST System and VITEK®… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST System | 2026 | 0 |
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?
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. 2024, 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 for quantitative and qualitative antimicrobial susceptibility testing (AST) of organisms direct from positive blood culture. The VITEK REVEAL AST System does not provide organism identification. 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…
Read the full statement (694 words)
The VITEK REVEAL AST System is an automated system for quantitative and qualitative antimicrobial susceptibility testing (AST) of organisms direct from positive blood culture. The VITEK REVEAL AST System does not provide organism identification.
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. 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. Organism identification is required for AST result interpretation and reporting.
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. Test results from the VITEK REVEAL AST System should be interpreted 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. Sub-culturing is necessary to support further testing for: bacteria and antimicrobials not on the VITEK REVEAL GN AST Assay panel, inconclusive results, epidemiologic testing, recovery of organisms present in positive blood cultures samples, and susceptibility testing of bacteria in polymicrobial samples.
The VITEK REVEAL GN AST Assay tests the following antimicrobial agents with the specific target organisms identified below:
Amikacin: Acinetobacter baumannii-calcoaceticus complex, Citrobacter freundii (including Citrobacter freundii complex), Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens
Amoxicillin/clavulanate: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis
Ampicillin/sulbactam: Escherichia coli, Klebsiella oxytoca, Proteus mirabilis
Aztreonam: Citrobacter freundii (including C. freundii complex), Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae (including K. pneumoniae group), Pseudomonas aeruginosa
Cefepime: Citrobacter koseri (syn. C. diversus), Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella species (including K. pneumoniae group and K. aerogenes), Klebsiella oxytoca, Pseudomonas aeruginosa
Cefotaxime: Acinetobacter baumannii-calcoaceticus complex, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group
Ceftazidime: Acinetobacter baumannii-calcoaceticus complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group
Ceftazidime/avibactam: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae (including K. pneumoniae group), Proteus mirabilis, Pseudomonas aeruginosa
Ceftolozane/tazobactam: Citrobacter koseri, Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa
Ceftriaxone: Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae (including K. pneumoniae group), Proteus mirabilis
Cefuroxime: Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae group, Klebsiella oxytoca, Proteus mirabilis
Ciprofloxacin: 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, Pseudomonas aeruginosa, Serratia marcescens
Ertapenem: Escherichia coli, Klebsiella pneumoniae (including K. pneumoniae group), Proteus mirabilis, Proteus vulgaris
Gentamicin: Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens
Imipenem: Acinetobacter baumannii-calcoaceticus complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group, Pseudomonas aeruginosa, Serratia marcescens
Levofloxacin: 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, Pseudomonas aeruginosa, Serratia marcescens
Meropenem: Acinetobacter baumannii-calcoaceticus complex, Enterobacter cloacae (including E. cloacae complex), Escherichia coli, Klebsiella pneumoniae (including K. pneumoniae group), Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens
Meropenem/vaborbactam: 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: Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae (including K. pneumoniae group), Proteus vulgaris
Tetracycline: Acinetobacter baumannii-calcoaceticus complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group
Tobramycin: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens
Trimethoprim/sulfamethoxazole: Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae group
ESBL Confirmation test: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae group
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230675: 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 4, 2026. https://510kreport.com/device/K230675
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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