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 Code | QSE |
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 |