FDA product code NGZ: Susceptibility Test Plate, Antifungal
NGZ is the FDA product code for susceptibility test plate, antifungal. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 21 510(k) submissions under NGZ, 6 in the last five years, from 6 different applicants. The average 510(k) review took 231 days (median 227); 174 days on average over the last three years. FDA has posted 4 recalls for NGZ devices, 3 initiated in the last five years.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Susceptibility Test Plate, Antifungal |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for NGZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 28 |
| 2021 | 1 | 211 |
| 2023 | 3 | 209 |
| 2024 | 2 | 262 |
| 2025 | 1 | 85 |
Compare with all 510(k) review times · Search every NGZ clearance
Top NGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| bioMerieux, Inc. | 10 | 2024-06-12 |
| Thermo Fisher Scientific | 5 | 2025-02-27 |
| Trek Diagnostic Systems, Inc. | 3 | 2009-06-04 |
| Trek Diagnostic Systems | 1 | 2014-01-31 |
| Ab Biomerieux | 1 | 2009-11-02 |
1 more applicants have NGZ clearances. See the full list in Caduvo.
Most recent NGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243738 | Thermo Fisher Scientific | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | 2025-02-27 | 85 |
| K232967 | bioMerieux, Inc. | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | 2024-06-12 | 265 |
| K232963 | bioMerieux, Inc. | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | 2024-06-07 | 260 |
| K231433 | Thermo Fisher Scientific | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL | 2023-08-31 | 106 |
| K221198 | Thermo Fisher Scientific | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL | 2023-03-10 | 318 |
Recalls for NGZ devices
4 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-03-24.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code NGZ?
NGZ is the FDA product code for susceptibility test plate, antifungal. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is NGZ?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code NGZ?
Across 21 cleared submissions the average was 231 days from receipt to decision (median 227).
Which companies have the most NGZ clearances?
bioMerieux, Inc. (10); Thermo Fisher Scientific (5); Trek Diagnostic Systems, Inc. (3); Trek Diagnostic Systems (1); Ab Biomerieux (1).
Have NGZ devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2026-03-24.
Next steps
- Run an FDA pathway report with predicate devices for product code NGZ
- Run a recall and safety report across every NGZ manufacturer
- Watch product code NGZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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