Etest for Antifungal Suscepttibility Testing
FDA 510(k) K040560 · Ab Biodisk
510(k) numberK040560
Submission
- Device name
- Etest for Antifungal Suscepttibility Testing
- Applicant
- Ab Biodisk
Solna, SE - Received
- March 3, 2004
- Decision date
- July 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)NGZ · Traditional | bioMerieux, Inc. | 06/12/2024SE |
| 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 |
More from bioMerieux, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K081325 | Etest Doripenem - Antimicrobial Susceptibility Test - Mic at 0.002-32 Ug/MlJWY · Traditional | 07/24/2008SE |
| K052366 | Etest Tigecycline Gram Positive and Gram Negative Aerobic Bacteria, Streptococcus Spp.…JWY · Traditional | 10/13/2005SE |
| K042392 | DaptomycinJWY · Traditional | 12/13/2004SE |
| K042390 | Etest for GemifloxacinJWY · Traditional | 11/19/2004SE |
| K021445 | Etest Cefditoren for S. Pneumoniae and H. InfluenzaeJWY · Traditional | 06/06/2002SE |
| K020748 | Etest ErtapenemJWY · Traditional | 04/29/2002SE |
| K010363 | Etest MeropenemJWY · Traditional | 04/09/2001SE |
| K002139 | Etest LinezolidLTX · Traditional | 11/08/2000SE |
| K001547 | Etest Esbl Ct/Ctl Strip; Etest Esbl Tz/Tzl StripJWY · Traditional | 08/07/2000SE |
| K000596 | Etest GatifloxacinJWY · Traditional | 05/22/2000SE |
Questions and answers
When was Etest for Antifungal Suscepttibility Testing cleared by the FDA?
Etest for Antifungal Suscepttibility Testing (K040560) received a 510(k) decision of Substantially Equivalent on July 27, 2004, 146 days after the submission was received.
What is the product code of K040560?
The FDA product code is NGZ – Susceptibility Test Plate, Antifungal, a Class II (moderate risk) device regulated under 21 CFR 866.1640.