# K221420: AlphaID™ At Home Genetic Health Risk Service

- Pathway: 510(k) (Traditional)
- Applicant: Progenika Biopharma S.A., A Grifols Company
- Decided: Oct 27, 2022 after 164 days
- Product code: PTA (Genetic Variant Detection And Health Risk Assessment System)
- Device class: 2
- Regulation: 21 CFR 866.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160026: Genetic Variant Detection And Health Risk Assessment System Summary page 9.

## Indications for use
The AlphalD™ At Home Genetic Health Risk Service uses qualitative genotyping to detect clinically relevant genetic variants associated with alpha-1 antitrypsin deficiency (AATD) in genomic DNA isolated from human saliva collected from individuals > 18 years with ORAcollect-Dx OCD-100.014 for the purpose of reporting and interpreting Genetic Health Risks (GHR). This Service is indicated for reporting 14 genetic variants in the SERPINA1 gene: PI*S; PI*Z; PI*[; PI*M procida; PI*M malton; PI*S iiyama; PI*Q0 granite falls; PI*QO0 west; PI*Q0 bellingham; PI*F; PI*P lowell; PI*Q0 mattawa; P1*Q0 clayton, and PI*M heerlen. The report describes if a person is at an increased risk of developing either lung and/or liver disease linked to AATD. The report does not describe a person’s overall risk of developing lung and/or liver disease. AATD is more common in persons of European descent.

Source page: https://510kreport.com/device/K221420
Methodology: https://510kreport.com/methodology