510(k) · Cleared
ClearedAlphaID™ At Home Genetic Health Risk Service
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Progenika Biopharma S.A., A Grifols Company · PTA Genetic Variant Detection And Health Risk Assessment System
Cleared on Oct 27, 2022 as substantially equivalent to DEN160026 (unknown applicant, ) after a 164-day review.
- Decided
- Oct 27, 2022
- Review
- 164 days
- Class
- Class II
- Product code
- PTA
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PTA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PTA device
- #1 K192073 Helix Genetic Health Risk App for late-onset…score 0.6 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN160026 | Genetic Variant Detection And Health Risk Assessment SystemSummary page 9…ice name(s): 23andMe Personal Genome Service (PGS) Genetic Health Risk Test (Alpha-1 Antitrypsin Deficiency) 2. Predicate 510(k) number(s): DEN160026 3. Comparison with predicate: Table 1: Predicate Device Comparison… | |
| † | DEN140044 | 23ANDME Personal Genome Service (Hereinafter Known as PGS) | 2015 |
| † | K212745 | ORAcollect®•Dx | 2022 |
| † | K211115 | A1AT Genotyping Test | 2021 |
| † | K171868 | A1AT Genotyping Test | 2017 |
| † | K192858 | A1AT Genotyping Test | 2019 |
| † | K152464 | ORAcollect.Dx | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN160026.
How does its category compare?
All PTA devicesPTA Genetic Variant Detection And Health Risk Assessment System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PTA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PTA
Too few PTA 510(k)s in any year since 2007 to give a median.
Recalls per year · PTA
No recall names PTA since 2007.
Adverse event reports per year · PTA
1in 2024
MAUDE reports naming product code PTA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (134 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221420: AlphaID™ At Home Genetic Health Risk Service.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221420
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026