AlphaID™ At Home Genetic Health Risk Service
FDA 510(k) clearance K221420 · decided 2022-10-27
Clearance details
- K-number
- K221420
- Device name
- AlphaID™ At Home Genetic Health Risk Service
- Applicant
- Progenika Biopharma S.A., A Grifols Company
- Decision
- Substantially Equivalent
- Date received
- 2022-05-16
- Decision date
- 2022-10-27
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- PTA
- Device class
- 2
- Regulation number
- 866.5950
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Derio, ES
- 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 |
| Helix Genetic Health Risk App for late-onset Alzheimer’s disease (K192073) | Helix Opco, LLC | 2020-12-23 |
| AncestryDNA Factor V Leiden Genetic Health Risk Test (K192944) | Ancestry Genomics, Inc. | 2020-08-13 |
| 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.