VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
FDA 510(k) K232967 · bioMerieux, Inc.
510(k) numberK232967
Submission
- Device name
- VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
- Applicant
- bioMerieux, Inc.
Hazelwood, MO, US - Received
- September 21, 2023
- Decision date
- June 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGZ – Susceptibility Test Plate, Antifungal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.
Other 510(k)s with product code NGZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of…NGZ · Traditional | Thermo Fisher Scientific | 02/27/2025SE |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)NGZ · Traditional | bioMerieux, Inc. | 06/07/2024SE |
| K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of…NGZ · Traditional | Thermo Fisher Scientific | 08/31/2023SE |
| K221198 | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of…NGZ · Traditional | Thermo Fisher Scientific | 03/10/2023SE |
| K221899 | The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of…NGZ · Traditional | Thermo Fisher Scientific | 01/20/2023SE |
| K211539 | Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of…NGZ · Traditional | Thermo Fisher Scientific | 12/15/2021SE |
| K181368 | VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)NGZ · Special | bioMerieux, Inc. | 06/20/2018SE |
| K151923 | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)NGZ · Traditional | bioMerieux, Inc. | 03/25/2016SE |
| K151817 | VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mLNGZ · Traditional | bioMerieux, Inc. | 02/18/2016SE |
| K133952 | Vitek 2 Ast Ys Flucytosine, Vitek 2 Ast Yeast FlucytosineNGZ · Traditional | bioMerieux, Inc. | 08/19/2014SE |
More from bioMerieux, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260160 | VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSAN · Traditional | 07/08/2026SE |
| 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 |
| 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 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) cleared by the FDA?
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (K232967) received a 510(k) decision of Substantially Equivalent on June 12, 2024, 265 days after the submission was received.
What is the product code of K232967?
The FDA product code is NGZ – Susceptibility Test Plate, Antifungal, a Class II (moderate risk) device regulated under 21 CFR 866.1640.