FDA product code PIV: Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use
PIV is the FDA product code for automated indirect immunofluorescence microscope and software-assisted system for clinical use. It is a Class II device, regulated under 21 CFR 866.4750 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under PIV. The average 510(k) review took 22 days (median 22). 1 De Novo request was granted under it.
Definition
Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescent technology. A trained operator must confirm all device generated results.
Classification
| Field | Value |
|---|---|
| Device name | Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use |
| Device class | Class II |
| Regulation | 21 CFR 866.4750 |
| 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 PIV clearance
Top PIV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 1 | 2015-11-24 |
Most recent PIV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153150 | Inova Diagnostics, Inc. | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 | 2015-11-24 | 22 |
Recalls for PIV devices
openFDA lists no recalls for product code PIV.
Frequently asked questions
What is FDA product code PIV?
PIV is the FDA product code for automated indirect immunofluorescence microscope and software-assisted system for clinical use. It is a Class II device, regulated under 21 CFR 866.4750 and reviewed by the Immunology panel.
What device class is PIV?
Class II, regulation 21 CFR 866.4750. Typical premarket route: 510(k).
How long does a 510(k) take for product code PIV?
Across 1 cleared submissions the average was 22 days from receipt to decision (median 22).
Which companies have the most PIV clearances?
Inova Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PIV
- Run a recall and safety report across every PIV manufacturer
- Watch product code PIV 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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