JWY · Manual Antimicrobial Susceptibility Test Systems
Microbiology · 21 CFR 866.1640 · Class 2
Overview
| Product Code | JWY |
|---|---|
| Device Name | Manual Antimicrobial Susceptibility Test Systems |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 441)
Showing 20 most recent of 441 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | Liofilchem s.r.l. | Apr 17, 2026 | SESE |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | Liofilchem s.r.l. | Oct 2, 2025 | SESE |
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | Thermo Fisher Scientific | Sep 25, 2025 | SESE |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL | Thermo Fisher Scientific | Sep 5, 2025 | SESE |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL | Thermo Fisher Scientific | Aug 28, 2025 | SESE |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Liofilchem s.r.l. | Aug 20, 2025 | SESE |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Thermo Fisher Scientific | Jun 30, 2025 | SESE |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. | Thermo Fisher Scientific | Jun 20, 2025 | SESE |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) | Biomérieux | Jun 12, 2025 | SESE |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | Thermo Fisher Scientific | May 22, 2025 | SESE |
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | Biomerieux S.A. | Apr 30, 2025 | SESE |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific | Apr 15, 2025 | SESE |
| K243201 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL | Thermo Fisher Scientific | Feb 10, 2025 | SESE |
| K242905 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL | Thermo Fisher Scientific | Feb 10, 2025 | SESE |
| K243202 | MTS Ceftobiprole 0.002-32 µg/mL | Liofilchem s.r.l. | Jan 30, 2025 | SESE |
| K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL | Thermo Fisher Scientific | Dec 19, 2024 | SESE |
| K242653 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL | Thermo Fisher Scientific | Dec 5, 2024 | SESE |
| K242657 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL | Thermo Fisher Scientific | Nov 26, 2024 | SESE |
| K242021 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. | Thermo Fisher Scientific | Oct 9, 2024 | SESE |
| K241967 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. | Thermo Fisher Scientific | Oct 1, 2024 | SESE |
Top Applicants
- Ab Biodisk — 61 clearances
- Thermo Fisher Scientific — 47 clearances
- Trek Diagnostic Systems, Inc. — 44 clearances
- Pasco Laboratories, Inc. — 39 clearances
- Liofilchem s.r.l. — 35 clearances
