Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

NVI · Class II — Moderate Risk (510(k) clearance required) · Clinical Toxicology · 21 CFR 862.3100

Classification

FDA Product Code: NVI
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.3100
Review panel: IM
Medical specialty: Clinical Toxicology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown