Device |
alpha-l-iduronidase (idua) newborn screening test system |
Definition |
Intended for quantitative measurement of the activity of alpha-L-iduronidase (IDUA) from newborn dried blood spot specimens. |
Physical State |
Neonatal screening |
Technical Method |
Quantitative fluorimetric enzymatic activity assay |
Target Area |
Newborn dried blood spot specimens |
Regulation Medical Specialty |
Clinical Chemistry |
Review Panel |
Clinical Chemistry |
Product Code | PQT |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Submission Type |
510(k)
|
Regulation Number |
862.1488
|
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
|
Accredited Persons
|