FDA product code NCW: System, Test, Her-2/Neu, Monitoring
NCW is the FDA product code for system, test, her-2/neu, monitoring. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under NCW, from 2 different applicants. The average 510(k) review took 270 days (median 298). FDA has posted 1 recall for NCW devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Her-2/Neu, Monitoring |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NCW clearance
Top NCW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bayer Corp. | 2 | 2003-01-30 |
| Oncogene Science, Inc. | 1 | 2000-09-29 |
Most recent NCW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K024017 | Bayer Corp. | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | 2003-01-30 | 57 |
| K994112 | Oncogene Science, Inc. | MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) | 2000-09-29 | 298 |
| K992228 | Bayer Corp. | BAYER IMMUNO 1 HER-2/NEU ASSAY | 2000-09-29 | 455 |
Recalls for NCW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-25.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code NCW?
NCW is the FDA product code for system, test, her-2/neu, monitoring. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is NCW?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code NCW?
Across 3 cleared submissions the average was 270 days from receipt to decision (median 298).
Which companies have the most NCW clearances?
Bayer Corp. (2); Oncogene Science, Inc. (1).
Have NCW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-08-25.
Next steps
- Run an FDA pathway report with predicate devices for product code NCW
- Run a recall and safety report across every NCW manufacturer
- Watch product code NCW 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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