# K253316: PhAST instrument and PhAST Blood Culture Gram-negative Panel

- Pathway: 510(k) (Traditional)
- Applicant: Phast Corp.
- Decided: Jun 26, 2026 after 269 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: 1 generation back to DEN160032 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160032: Accelerate Pheno system, Accelerate Phenotest BC Kit, Accelerate Diagnotics (2017) Summary page 6.

## Indications for use
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)

Source page: https://510kreport.com/device/K253316
Methodology: https://510kreport.com/methodology