NVI — Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease Class II
FDA product code NVI covers "Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease", a Class II medical device regulated under 21 CFR 862.3100. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NVI
- Device Class
- Class II
- Regulation Number
- 862.3100
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Clinical Toxicology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K043341 | bio-rad laboratories | BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOP | October 27, 2005 |