FDA product code PNI: Aquaporin-4 Autoantibody
PNI is the FDA product code for aquaporin-4 autoantibody. It is a Class II device, regulated under 21 CFR 866.5665 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under PNI. The average 510(k) review took 7 days (median 7). 1 De Novo request was granted under it.
Definition
For the determination of autoantibodies to Aquaporin-4 in human serum and plasma. The test may be useful as an aid in the diagnosis of Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorders (NMOSD). The test is not to be used alone and is to be used in conjunction with other clinical and radiological (MRI) laboratory findings.
Classification
| Field | Value |
|---|---|
| Device name | Aquaporin-4 Autoantibody |
| Device class | Class II |
| Regulation | 21 CFR 866.5665 |
| 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 PNI clearance
Top PNI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kronus, Inc. | 1 | 2016-07-22 |
Most recent PNI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161951 | Kronus, Inc. | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | 2016-07-22 | 7 |
Recalls for PNI devices
openFDA lists no recalls for product code PNI.
Frequently asked questions
What is FDA product code PNI?
PNI is the FDA product code for aquaporin-4 autoantibody. It is a Class II device, regulated under 21 CFR 866.5665 and reviewed by the Immunology panel.
What device class is PNI?
Class II, regulation 21 CFR 866.5665. Typical premarket route: 510(k).
How long does a 510(k) take for product code PNI?
Across 1 cleared submissions the average was 7 days from receipt to decision (median 7).
Which companies have the most PNI clearances?
Kronus, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PNI
- Run a recall and safety report across every PNI manufacturer
- Watch product code PNI 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.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times