DEN190035 is an FDA 510(k) submission for the Helix Laboratory Platform. This device is classified as a Whole Exome Sequencing Constituent Device (Class II - Special Controls, product code QNC).
Submitted by Helix Opco, LLC (Toronto, CA). The FDA issued a Not Cleared (DENG) decision on December 23, 2020.
This device falls under the Medical Genetics FDA review panel. Regulated under 21 CFR 866.6000. 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) Number | DEN190035 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | August 02, 2019 |
| Decision Date | December 23, 2020 |
| Days to Decision | 509 days |
| Submission Type | Direct |
| Review Panel | Medical Genetics (MG) |
| Summary | - |
| Product Code | QNC - Whole Exome Sequencing Constituent Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6000 |
| 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. |