Device |
25-oh-vitamin d mass spectrometry test system |
Regulation Description |
Total 25-hydroxyvitamin D mass spectrometry test system. |
Definition |
A 25-OH-Vitamin D Mass Spectrometry test system is intended to for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry. |
Physical State |
Mass spectrometer, liquid chromatography-tandem mass spectrometer |
Technical Method |
Liquid chromatography-tandem mass spectrometry (LC-MS/MS), mass spectrometry |
Target Area |
In vitro diagnostic use |
Regulation Medical Specialty |
Clinical Chemistry |
Review Panel |
Clinical Chemistry |
Product Code | PSL |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Submission Type |
510(K) Exempt
|
Regulation Number |
862.1840
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act. |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |