FDA product code NWM: Immunoassay, Anti-Seizure Drug
NWM is the FDA product code for immunoassay, anti-seizure drug. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 5 510(k) submissions under NWM, from 2 different applicants. The average 510(k) review took 203 days (median 168).
Definition
To aid in management of patients treated with anti-seizure drug.
Classification
| Field | Value |
|---|---|
| Device name | Immunoassay, Anti-Seizure Drug |
| Device class | Class II |
| Regulation | 21 CFR 862.3350 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NWM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 469 |
Top NWM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ark Diagnostics, Inc. | 3 | 2021-08-05 |
| Seradyn, Inc. | 2 | 2007-05-17 |
Most recent NWM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201089 | Ark Diagnostics, Inc. | ARK Lacosamide Assay | 2021-08-05 | 469 |
| K091884 | Ark Diagnostics, Inc. | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 | 2009-12-09 | 168 |
| K083799 | Ark Diagnostics, Inc. | TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 | 2009-04-16 | 115 |
| K070645 | Seradyn, Inc. | SERADYN QMS TOPIRAMATE | 2007-05-17 | 70 |
| K051211 | Seradyn, Inc. | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | 2005-11-18 | 191 |
Recalls for NWM devices
openFDA lists no recalls for product code NWM.
Frequently asked questions
What is FDA product code NWM?
NWM is the FDA product code for immunoassay, anti-seizure drug. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is NWM?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code NWM?
Across 5 cleared submissions the average was 203 days from receipt to decision (median 168).
Which companies have the most NWM clearances?
Ark Diagnostics, Inc. (3); Seradyn, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NWM
- Run a recall and safety report across every NWM manufacturer
- Watch product code NWM 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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