NVI

Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

Product code

NVI

Device name

Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

Device class

Class 2

21 CFR

21 CFR 862.3100

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).