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U.S. Department of Health and Human Services

Product Classification

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Device diagnostic software, k-nearest neighbor algorithm, autoimmune disease
Regulation Description Amphetamine test system.
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.
Regulation Medical Specialty Toxicology
Review Panel Immunology
Product CodeNVI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3100
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible