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U.S. Department of Health and Human Services

Product Classification
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Device alzheimer’s disease pathology assessment test
Definition In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents.
Physical State Immunoassay reagents, calibrators, controls, general microplate reader or automated instrument with software
Technical Method Enzyme-linked immunosorbent assay
Target Area Cerebral spinal fluid (CSF), but other specimen types may be possible
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeQSE
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5840
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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