FDA product code NJW: Control Material, Her-2/Neu, Immunohistochemistry
NJW is the FDA product code for control material, her-2/neu, immunohistochemistry. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under NJW, 1 in the last five years, from 2 different applicants. The average 510(k) review took 230 days (median 230).
Definition
Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.
Classification
| Field | Value |
|---|---|
| Device name | Control Material, Her-2/Neu, Immunohistochemistry |
| Device class | Class II |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NJW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 207 |
Compare with all 510(k) review times · Search every NJW clearance
Top NJW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Cell Standards, Inc. | 1 | 2022-08-15 |
| Qc Sciences, LLC | 1 | 2003-06-18 |
Most recent NJW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220163 | Boston Cell Standards, Inc. | Her-2, ER, PR IHControls | 2022-08-15 | 207 |
| K023335 | Qc Sciences, LLC | QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) | 2003-06-18 | 254 |
Recalls for NJW devices
openFDA lists no recalls for product code NJW.
Frequently asked questions
What is FDA product code NJW?
NJW is the FDA product code for control material, her-2/neu, immunohistochemistry. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is NJW?
Class II, regulation 21 CFR 864.1860. Typical premarket route: 510(k).
How long does a 510(k) take for product code NJW?
Across 2 cleared submissions the average was 230 days from receipt to decision (median 230).
Which companies have the most NJW clearances?
Boston Cell Standards, Inc. (1); Qc Sciences, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NJW
- Run a recall and safety report across every NJW manufacturer
- Watch product code NJW 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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