K192944 is an FDA 510(k) clearance for the AncestryDNA Factor V Leiden Genetic Health Risk Test. This device is classified as a Genetic Variant Detection And Health Risk Assessment System (Class II - Special Controls, product code PTA).
Submitted by Ancestry Genomics, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 13, 2020, 300 days after receiving the submission on October 18, 2019.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 866.5950. A Qualitative In Vitro Molecular Test That Detects Variants In Genomic Dna Isolated From Human Specimens. This Assessment System Provides Users With A Genetic Health Risk Assessment Of Developing A Disease And Is Intended To Inform Users Of Lifestyle Choices And/or Encourage Conversations With A Healthcare Professional. This Assessment System Is For Over-the-counter Use. This Device Does Not Determine The Person?s Overall Risk Of Developing A Disease..
| 510(k) Number | K192944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2019 |
| Decision Date | August 13, 2020 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | PTA — Genetic Variant Detection And Health Risk Assessment System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5950 |
| Definition | A Qualitative In Vitro Molecular Test That Detects Variants In Genomic Dna Isolated From Human Specimens. This Assessment System Provides Users With A Genetic Health Risk Assessment Of Developing A Disease And Is Intended To Inform Users Of Lifestyle Choices And/or Encourage Conversations With A Healthcare Professional. This Assessment System Is For Over-the-counter Use. This Device Does Not Determine The Person?s Overall Risk Of Developing A Disease. |