| Device |
quality control material, genetics, dna |
| Regulation Description |
Quality control material for cystic fibrosis nucleic acid assays. |
| Definition |
Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic dna controls and cell-line based controls. |
| Physical State |
This type of device includes synthetic DNA controls and cell-line based controls. |
| Technical Method |
No method, quality control material |
| Target Area |
No target area, IVD |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Immunology |
|---|
| Product Code | NZB |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
866.5910
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| 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
|
|---|
| Guidance Document
|
| Third Party Review |
Not Third Party Eligible |
