The instrument
Four independent, random-access bays—no batching needed.
PhAST BC GN Panel – At a glance
| Assay type | Phenotypic antimicrobial susceptibility test(single-cell imaging) |
|---|---|
| Time from cartridge loading to susceptibility results (mean ± std) | 99 ± 6 min · Enterobacterales and Acinetobacter spp.141 ± 6 min · Pseudomonas aeruginosa |
| Hands-on time | Under 1 minute |
| Sample type | Positive blood culture, reported as monomicrobial Gram-negative |
| Organism ID | Organism identity must be obtained using an FDA-cleared method before categorical interpretation is reported |
| Antibiotics | 15 |
| Result type | Categorical interpretation: S / SDD / I / R |
| Internet connection required | Yes, for cloud data processing |
| Capacity | 4 independent, random-access bays per instrument |
| Throughput | 12 samples per instrument per 8-hour shift |
| Dimensions and weight | 720 × 722 × 558 mm (W × D × H) · 65.5 kg |
Regulatory clearance
The PhAST Blood Culture Gram-negative Panel and the PhAST instrument were cleared by the FDA on June 26, 2026, under 510(k) number K253316. FDA 510(k) summary, K253316 (opens in a new tab)
The FDA determined a CLIA categorization of “Moderate Complexity” for the PhAST BC GN Panel.
Clinical performance
The performance of the PhAST BC GN Panel was assessed in a multi-center clinical trial for FDA clearance, in comparison with the reference method of broth microdilution, using FDA-recognized breakpoints.
For full performance statistics please review the FDA 510(k) summary, K253316 (opens in a new tab)
| Organism group | Categorical agreement | Very major error rate | Major error rate | Minor error rate |
|---|---|---|---|---|
| Overall | 97.3% | 0.2% | 0.8% | 2.0% |
| Enterobacterales | 97.3% | 0.3% | 0.9% | 2.0% |
| Pseudomonas aeruginosa | 97.9% | 0.0% | 0.0% | 2.1% |
| Acinetobacter spp. | 96.9% | 0.0% | 1.3% | 2.6% |
How to run the PhAST BC GN Panel
Hands-on time is under one minute.
Prepare the sample using the provided kit, load the sample onto the cartridge, scan its barcode and the sample barcode, remove the cartridge's back-film and load it into the instrument.
The instrument and the cartridge
The cartridge
A single-use cartridge takes 60 µL of prepared sample and carries all 15 antibiotics.
The 15 antibiotics
- Amikacin
- Ampicillin/sulbactam
- Aztreonam
- Cefepime
- Ceftazidime
- Ceftazidime/avibactam
- Ceftriaxone
- Ciprofloxacin
- Ertapenem
- Gentamicin
- Levofloxacin
- Meropenem
- Piperacillin/tazobactam
- Tobramycin
- Trimethoprim/sulfamethoxazole
If you want to evaluate the PhAST BC GN Panel, please contact us.