ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
FDA 510(k) K260447 · bioMérieux SA
510(k) numberK260447
Submission
- Device name
- ETEST Gepotidacin (GEP) (0.016-256 µg/mL)
- Applicant
- bioMérieux SA
Marcy-L'Etoile, FR - Received
- February 11, 2026
- Decision date
- April 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWY – Manual Antimicrobial Susceptibility Test Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code JWY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260696 | MTS Gepotidacin 0.016-256 µg/mLJWY · Traditional | Liofilchem s.r.l. | 04/17/2026SE |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLJWY · Traditional | Liofilchem s.r.l. | 10/02/2025SE |
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the…JWY · Traditional | Thermo Fisher Scientific | 09/25/2025SE |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with…JWY · Traditional | Thermo Fisher Scientific | 09/05/2025SE |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the…JWY · Traditional | Thermo Fisher Scientific | 08/28/2025SE |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)JWY · Traditional | Liofilchem s.r.l. | 08/20/2025SE |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in…JWY · Traditional | Thermo Fisher Scientific | 06/30/2025SE |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or…JWY · Traditional | Thermo Fisher Scientific | 06/20/2025SE |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)JWY · Traditional | Biomérieux | 06/12/2025SE |
| K242659 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the…JWY · Traditional | Thermo Fisher Scientific | 05/22/2025SE |
More from Thermo Fisher Scientific
| 510(k) | Device | Decision |
|---|---|---|
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)JWY · Traditional | 06/12/2025SE |
| K232395 | ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUDJWY · Traditional | 10/05/2023SE |
| K210793 | Vidas NephrocheckPIG · Traditional | 07/08/2022SE |
| K212849 | VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)LON · Special | 02/04/2022SE |
| K200512 | ETEST Plazomicin (PLZ) (0.016-256 µg/mL)JWY · Traditional | 05/07/2020SE |
Questions and answers
When was ETEST Gepotidacin (GEP) (0.016-256 µg/mL) cleared by the FDA?
ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (K260447) received a 510(k) decision of Substantially Equivalent on April 21, 2026, 69 days after the submission was received.
What is the product code of K260447?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.