Product code NVI

Device name

Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

Medical specialty

Clinical Toxicology

Device class

2

Regulation number

862.3100

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset