Whole Exome Sequencing Constituent Device
The Whole Exome Sequencing Constituent Device is a Medical Genetics diagnostic device intended for germline whole exome sequencing of genomic DNA isolated from human specimens, generating DNA sequence data for use as input into FDA-authorized clinical germline DNA assays validated for use with this device. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 866.6000, and is reviewed by the Pathology panel under the Medical Genetics specialty. It carries product code QNC and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QNC
- Device Class
- FDA class 2
- Regulation Number
- 866.6000
- Medical Specialty
- Medical Genetics
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN190035 | Helix Laboratory Platform | Dec 23, 2020 | Unknown | Helix Opco, LLC |