| Device |
quality control material, genetics, rna |
| Regulation Description |
Quality control material for cystic fibrosis nucleic acid assays. |
| Definition |
RNA quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision or sample concentration and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic RNA controls and cell-line based controls. |
| Physical State |
The RNA quality control material may consist of synthetic RNA, plasmid, or cell line derived RNA at specific concentrations. The control material may consist of a single or multiple controls or at a single or multiple concentrations and may be traceable to recognized standards. |
| Technical Method |
For use with qualitative or quantitative nucleic acid amplification tests. |
| Target Area |
IVD |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Molecular Genetics |
|---|
| Product Code | QIG |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| 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 |
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 |
