FDA product code NQZ: Antigen, Invasive Fungal Pathogens
NQZ is the FDA product code for antigen, invasive fungal pathogens. It is a Class II device, regulated under 21 CFR 866.3050 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under NQZ. The average 510(k) review took 77 days (median 77). 1 De Novo request was granted under it. FDA has posted 2 recalls for NQZ devices, 1 initiated in the last five years.
Definition
Invasive fungal pathogen assays are devices that consist of antigens, antisera, or proteases used in serological assays for the presumptive diagnosis of fungal infection in serum or plasma. The assay is indicated for use in patients with symptoms of, or medical conditions predisposing the patient to invasive fungal infection. The device can be used as an aid in the diagnosis of deep seated mycoses and fungemias. A positive result does not indicate which class of fungi may be causing infection. The assays should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Invasive Fungal Pathogens |
| Device class | Class II |
| Regulation | 21 CFR 866.3050 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for NQZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 77 |
Compare with all 510(k) review times · Search every NQZ clearance
Top NQZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Associates of Cape Cod, Inc. | 1 | 2019-07-17 |
Most recent NQZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191167 | Associates of Cape Cod, Inc. | Fungitell STAT | 2019-07-17 | 77 |
Recalls for NQZ devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-08-17.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code NQZ?
NQZ is the FDA product code for antigen, invasive fungal pathogens. It is a Class II device, regulated under 21 CFR 866.3050 and reviewed by the Microbiology panel.
What device class is NQZ?
Class II, regulation 21 CFR 866.3050. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQZ?
Across 1 cleared submissions the average was 77 days from receipt to decision (median 77).
Which companies have the most NQZ clearances?
Associates of Cape Cod, Inc. (1).
Have NQZ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-08-17.
Next steps
- Run an FDA pathway report with predicate devices for product code NQZ
- Run a recall and safety report across every NQZ manufacturer
- Watch product code NQZ 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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