AncestryDNA Factor V Leiden Genetic Health Risk Test
FDA 510(k) clearance K192944 · decided 2020-08-13
Clearance details
- K-number
- K192944
- Device name
- AncestryDNA Factor V Leiden Genetic Health Risk Test
- Applicant
- Ancestry Genomics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-10-18
- Decision date
- 2020-08-13
- Days to decision
- 300 days
- Clearance type
- Traditional
- Product code
- PTA
- Device class
- 2
- Regulation number
- 866.5950
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GlutenID Celiac Genetic Health Risk Test (K241456) | Targeted Genomics, LLC | 2025-01-07 |
| AlphaID™ At Home Genetic Health Risk Service (K221420) | Progenika Biopharma S.A., A Grifols Company | 2022-10-27 |
| Helix Genetic Health Risk App for late-onset Alzheimer’s disease (K192073) | Helix Opco, LLC | 2020-12-23 |
| 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia (DEN160026) | 23AndMe, Inc. | 2017-04-06 |
Recalls involving this device
No recalls on record reference this clearance.