VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
FDA 510(k) K260160 · bioMerieux, Inc.
510(k) numberK260160
Submission
- Device name
- VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- Applicant
- bioMerieux, Inc.
Hazelwood, MO, US - Received
- January 20, 2026
- Decision date
- July 8, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- SAN – Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1650
- Specialty
- Microbiology
Automated system that performs antimicrobial susceptibility testing using positive blood culture samples
Other 510(k)s with product code SAN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253316 | PhAST instrument and PhAST Blood Culture Gram-negative PanelSAN · Traditional | Phast Corp. | 06/26/2026SE |
| K253573 | ASTar BC G- KitSAN · Traditional | Q-Linea AB | 04/15/2026SE |
| K251875 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemSAN · Traditional | Affinity Biosensors, LLC | 10/27/2025SE |
| K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemSAN · Traditional | Affinity Biosensors, LLC | 10/23/2024SE |
| K230675 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSAN · Traditional | Specific Diagnostics, LLC | 06/20/2024SE |
| K221688 | ASTar BC G- Kit and ASTar InstrumentSAN · Traditional | Q-Linea AB | 04/26/2024SE |
| K211815 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemSAN · Traditional | Affinity Biosensors | 04/02/2024SE |
More from Affinity Biosensors
| 510(k) | Device | Decision |
|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceLON · Traditional | 04/15/2026SE |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)LON · Traditional | 03/26/2026SE |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)LON · Traditional | 08/21/2025SE |
| K234012 | Vitek Compact ProLON · Traditional | 03/14/2025SE |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)NGZ · Traditional | 06/12/2024SE |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)NGZ · Traditional | 06/07/2024SE |
| K240279 | Vidas Tbi (Gfap, UCH-L1)QAT · Traditional | 05/01/2024SE |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)LON · Traditional | 03/11/2024SE |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus…LON · Traditional | 10/23/2023SE |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin…LON · Traditional | 07/05/2023SE |
Questions and answers
When was VITEK REVEAL GN AST Assay and VITEK REVEAL AST System cleared by the FDA?
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (K260160) received a 510(k) decision of Substantially Equivalent on July 8, 2026, 169 days after the submission was received.
What is the product code of K260160?
The FDA product code is SAN – Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples, a Class II (moderate risk) device regulated under 21 CFR 866.1650.