510(k) · Cleared
ClearedPhAST instrument and PhAST Blood Culture Gram-negative Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phast Corp. · SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
Cleared on Jun 26, 2026 as substantially equivalent to DEN160032 (Accelerate Diagnotics, 2017) after a 269-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Jun 26, 2026
- Review
- 269 days
- Class
- Class II
- Product code
- SAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160032 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backDEN160032 Accelerate Pheno system, Accelerate Phenotest BC KitAccelerate Diagnotics · 2017
- This deviceK253316 PhAST instrument and PhAST Blood Culture Gram-negative PanelPhast Corp. · 2026
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) | K253316 | PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | 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 |
|---|---|---|---|
| * | DEN160032 | Accelerate Pheno system, Accelerate Phenotest BC KitSummary page 6… 21 CFR 866.1650 Regulatory Class: Class II Product Code: SAN, LON Predicate Device: Accelerate Pheno System, Accelerate PhenoTest BC Kit, DEN160032 Confidential 510(k) Summary… | 2017 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate DEN160032.
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 PhAST Blood Culture Gram-negative Panel (PhAST BC GN Panel) is an in vitro diagnostic assay for qualitative (breakpoint) determination of antimicrobial susceptibility testing (AST) of pathogenic gram-negative bacteria from positive blood cultures (BC) and is intended to be used with the PhAST instrument. The PhAST BC GN Panel is a phenotypic test that utilizes video microscopy and analysis of single-cell phenotypes to determine susceptibility based…
Read the full statement (631 words)
The PhAST Blood Culture Gram-negative Panel (PhAST BC GN Panel) is an in vitro diagnostic assay for qualitative (breakpoint) determination of antimicrobial susceptibility testing (AST) of pathogenic gram-negative bacteria from positive blood cultures (BC) and is intended to be used with the PhAST instrument. The PhAST BC GN Panel is a phenotypic test that utilizes video microscopy and analysis of single-cell phenotypes to determine susceptibility based on categorical interpretation. The PhAST BC GN Panel does not provide organism identification. The PhAST BC GN Panel is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system and reported as monomicrobial gram-negative specimens by gram staining. Organism identity must be entered into the PhAST instrument or PhAST web application before categorical interpretation (Susceptible, Susceptible Dose-Dependent, Intermediate, Resistant, S/SDD/I/R) of antimicrobial susceptibility is reported. The PhAST BC GN Panel contains 15 antimicrobials.
The PhAST BC GN Panel is intended to aid in the diagnosis and treatment of individuals suspected of bloodstream infection by a healthcare provider. Results should not be used as the sole basis for patient management decisions.
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 PhAST BC GN Panel 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 PhAST BC GN Panel, inconclusive results, epidemiologic testing, recovery of organisms present in positive blood cultures samples, and susceptibility testing of bacteria in polymicrobial samples.
Testing is indicated for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The PhAST BC GN Panel with the PhAST instrument has demonstrated acceptable performance with the following organisms:
Amikacin: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Serratia marcescens)
Ampicillin/sulbactam: Acinetobacter spp. (Acinetobacter baumannii complex)
Aztreonam: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus vulgaris group)
Cefepime: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens) and Pseudomonas aeruginosa
Ceftazidime: Acinetobacter spp. (Acinetobacter baumannii complex), Enterobacterales (Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens) and Pseudomonas aeruginosa
Ceftazidime/avibactam: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris group, Serratia marcescens) and Pseudomonas aeruginosa
Ceftriaxone: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis)
Ciprofloxacin: Enterobacterales (Citrobacter freundii complex, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens) and Pseudomonas aeruginosa
Ertapenem: Enterobacterales (Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis)
Gentamicin: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris group, Serratia marcescens)
Levofloxacin: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris group, Serratia marcescens) and Pseudomonas aeruginosa
Meropenem: Acinetobacter spp. (Acinetobacter baumannii complex), Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis) and Pseudomonas aeruginosa
Piperacillin/tazobactam: Acinetobacter spp. (Acinetobacter baumannii complex), Enterobacterales (Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae) and Pseudomonas aeruginosa
Tobramycin: Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Proteus vulgaris group) and Pseudomonas aeruginosa
Trimethoprim/sulfamethoxazole: Enterobacterales (Citrobacter koseri, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Serratia marcescens)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253316 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253316: PhAST instrument and PhAST Blood Culture Gram-negative Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253316
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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