FDA product code NOP: Elisa, Antibody, West Nile Virus
NOP is the FDA product code for elisa, antibody, west nile virus. It is a Class II device, regulated under 21 CFR 866.3940 and reviewed by the Microbiology panel. FDA has cleared 9 510(k) submissions under NOP, from 5 different applicants. The average 510(k) review took 190 days (median 136). 1 De Novo request was granted under it. FDA has posted 2 recalls for NOP devices.
Definition
The West Nile Virus ELISA is intended for the detection of IgG and IgM antibodies to West Nile Virus. Specimens may be serum or cerebral spinal fluid from symptomatic patients.
Classification
| Field | Value |
|---|---|
| Device name | Elisa, Antibody, West Nile Virus |
| Device class | Class II |
| Regulation | 21 CFR 866.3940 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NOP clearance
Top NOP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Focus Technologies, Inc. | 3 | 2004-06-30 |
| Euroimmun Us, Inc. | 2 | 2016-08-12 |
| Panbio Limited | 2 | 2004-10-20 |
| Spectral Diagnostics, Inc. | 1 | 2006-11-30 |
| Inbios Intl., Inc. | 1 | 2004-11-19 |
Most recent NOP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153308 | Euroimmun Us, Inc. | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | 2016-08-12 | 269 |
| K153303 | Euroimmun Us, Inc. | EUROIMMUN Anti-West Nile Virus ELISA (IgG) | 2016-08-10 | 268 |
| K052519 | Spectral Diagnostics, Inc. | SPECTRAL WEST NILE VIRUS IGM STATUS TEST | 2006-11-30 | 442 |
| K041817 | Inbios Intl., Inc. | WEST NILE DETECT IGM ELISA | 2004-11-19 | 136 |
| K041068 | Panbio Limited | WEST NILE VIRUS IGG INDIRECT ELISA | 2004-10-20 | 177 |
Recalls for NOP devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-10-03.
Frequently asked questions
What is FDA product code NOP?
NOP is the FDA product code for elisa, antibody, west nile virus. It is a Class II device, regulated under 21 CFR 866.3940 and reviewed by the Microbiology panel.
What device class is NOP?
Class II, regulation 21 CFR 866.3940. Typical premarket route: 510(k).
How long does a 510(k) take for product code NOP?
Across 9 cleared submissions the average was 190 days from receipt to decision (median 136).
Which companies have the most NOP clearances?
Focus Technologies, Inc. (3); Euroimmun Us, Inc. (2); Panbio Limited (2); Spectral Diagnostics, Inc. (1); Inbios Intl., Inc. (1).
Have NOP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2012-10-03.
Next steps
- Run an FDA pathway report with predicate devices for product code NOP
- Run a recall and safety report across every NOP manufacturer
- Watch product code NOP 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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