| Device |
high throughput dna sequence analyzer |
| Regulation Description |
High throughput genomic sequence analyzer for clinical use. |
| Definition |
A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample. |
| Physical State |
sequencing instrument and associated software |
| Technical Method |
A high throughput DNA sequence analyzer is an automated clinical multiplex instrument system intended to prepare, generate, measure and sort signals in order to analyze DNA molecules of amplicons from a clinical sample such as peripheral whole blood. Signals produced are measured and interpreted by accompanying software into DNA sequence information. |
| Target Area |
human genomic DNA from a clinical sample |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Toxicology |
|---|
| Product Code | PFF |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
862.2265
|
|---|
| 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
|
|---|
| Third Party Review |
Not Third Party Eligible |
