QNC — Whole Exome Sequencing Constituent Device Class II
FDA product code QNC covers "Whole Exome Sequencing Constituent Device", a Class II medical device regulated under 21 CFR 866.6000. Submissions are reviewed by the Medical Genetics panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QNC
- Device Class
- Class II
- Regulation Number
- 866.6000
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Medical Genetics
- Implant
- No
Definition
A whole exome sequencing constituent device is for germline whole exome sequencing of genomic deoxyribonucleic acid (DNA) isolated from human specimens. The DNA sequence generated by this device is intended as input for clinical germline DNA assays that have FDA marketing authorization and are intended for use with this device.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN190035 | helix opco | Helix Laboratory Platform | December 23, 2020 |