FDA product code NVI: Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
NVI is the FDA product code for diagnostic software, k-nearest neighbor algorithm, autoimmune disease. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under NVI. The average 510(k) review took 328 days (median 328). FDA has posted 1 recall for NVI devices.
Definition
The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests.
Classification
| Field | Value |
|---|---|
| Device name | Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease |
| Device class | Class II |
| Regulation | 21 CFR 862.3100 |
| Review panel | IM — Immunology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NVI clearance
Top NVI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad Laboratories, Inc. | 1 | 2005-10-27 |
Most recent NVI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K043341 | Bio-Rad Laboratories, Inc. | BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | 2005-10-27 | 328 |
Recalls for NVI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-11-13.
Frequently asked questions
What is FDA product code NVI?
NVI is the FDA product code for diagnostic software, k-nearest neighbor algorithm, autoimmune disease. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Immunology panel.
What device class is NVI?
Class II, regulation 21 CFR 862.3100. Typical premarket route: 510(k).
How long does a 510(k) take for product code NVI?
Across 1 cleared submissions the average was 328 days from receipt to decision (median 328).
Which companies have the most NVI clearances?
Bio-Rad Laboratories, Inc. (1).
Have NVI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-11-13.
Next steps
- Run an FDA pathway report with predicate devices for product code NVI
- Run a recall and safety report across every NVI manufacturer
- Watch product code NVI 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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