FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
K Number: K252014
·
Decision Aug 28, 2025
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
440
Applicant Total
64
Review Days
62
Basic Information
- Device Name
- The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
- K Number
- K252014
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thermo Fisher Scientific
- Date Received
- June 27, 2025
- Decision Date
- August 28, 2025
- Product Code
- JWY
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWY), ordered by most recent decision date.
ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
FDA 510(k)
FDA Class 2
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MTS Gepotidacin 0.016-256 µg/mL
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FDA Class 2
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MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
FDA 510(k)
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·Microbiology
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
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
FDA 510(k)
FDA Class 2
·Microbiology
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Thermo Fisher Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL | Sep 25, 2025 | Substantially Equivalent |
| 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 | Sep 5, 2025 | Substantially Equivalent |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Jun 30, 2025 | Substantially Equivalent |
| 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. | Jun 20, 2025 | Substantially Equivalent |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL | May 22, 2025 | Substantially Equivalent |
| K242658 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL | Apr 15, 2025 | Substantially Equivalent |
| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | Feb 27, 2025 | Substantially Equivalent |
| 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 | Feb 10, 2025 | Substantially Equivalent |
| 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 | Feb 10, 2025 | Substantially Equivalent |
| K243169 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL | Dec 19, 2024 | Substantially Equivalent |