FDA product code NJF: Antibodies, Anti-Actin, Anti-Smooth Muscle
NJF is the FDA product code for antibodies, anti-actin, anti-smooth muscle. It is a Class II device, regulated under 21 CFR 866.5120 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under NJF. The average 510(k) review took 123 days (median 123).
Definition
The device is used for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis.
Classification
| Field | Value |
|---|---|
| Device name | Antibodies, Anti-Actin, Anti-Smooth Muscle |
| Device class | Class II |
| Regulation | 21 CFR 866.5120 |
| 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 NJF clearance
Top NJF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 1 | 2002-09-20 |
Most recent NJF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K021648 | Inova Diagnostics, Inc. | QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA | 2002-09-20 | 123 |
Recalls for NJF devices
openFDA lists no recalls for product code NJF.
Frequently asked questions
What is FDA product code NJF?
NJF is the FDA product code for antibodies, anti-actin, anti-smooth muscle. It is a Class II device, regulated under 21 CFR 866.5120 and reviewed by the Immunology panel.
What device class is NJF?
Class II, regulation 21 CFR 866.5120. Typical premarket route: 510(k).
How long does a 510(k) take for product code NJF?
Across 1 cleared submissions the average was 123 days from receipt to decision (median 123).
Which companies have the most NJF clearances?
Inova Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NJF
- Run a recall and safety report across every NJF manufacturer
- Watch product code NJF 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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