Genetic health risk · 510(k) K221420

AlphaID: Alpha-1 antitrypsin deficiency, 14 variants

FDA record K221420: 510(k) cleared on October 27, 2022 for Progenika Biopharma (Grifols). It was decided after FDA last updated its Direct-to-Consumer Tests table (December 20, 2019); it appears in FDA's device database.

FDA recordK221420

FDA device name

AlphaID™ At Home Genetic Health Risk Service (text repaired: openFDA returns a Windows-1252 character as a control code)

Applicant (as FDA lists it)

Progenika Biopharma S.A., A Grifols Company

FDA decision

Substantially equivalent (cleared)

Decision date

October 27, 2022 (received May 16, 2022)

Product code

PTA

Regulation

21 CFR 866.5950

FDA database entry · FDA 510(k) file (PDF) · openFDA record

What the authorization says it may report

This Service is indicated for reporting 14 genetic variants in the SERPINA1 gene

The report describes if a person is at an increased risk of developing either lung and/or liver disease linked to AATD.

Genes or markers named: SERPINA1

Stated limitations

These 14 variants explain 95% of AATD cases.

The absence of a variant tested does not rule out the presence of other genetic variants that may be disease-related.

FDA classifies this test type under 21 CFR 866.5950, which says: “This assessment system is for over-the-counter use. This device does not determine the person's overall risk of developing a disease.” (21 CFR 866.5950)

What this record doesn't tell you

An FDA record says what a test was authorized to report on the decision date. It doesn't say whether the product is still sold, what it costs, or which version a kit in a store uses. Check the company's own label and report for the current claims.

FDA's general advice on direct-to-consumer tests: “Do not make any dietary or health-related decisions without first discussing your test results with your health care provider.” (U.S. Food and Drug Administration) On disease-risk results: “Remember that a positive result from a test does not mean that you will develop that disease or condition.” (U.S. Food and Drug Administration)

Other genetic health risk records

• 23andMe: Ten genetic health risk reports

  DEN160026 · De Novo request granted Apr 6, 2017 · 23andMe

  Hereditary thrombophilia (Factor V Leiden, prothrombin); Alpha-1 antitrypsin deficiency; Late-onset Alzheimer's disease; Parkinson's disease; Gaucher disease type 1; Factor XI deficiency; Celiac disease; G6PD deficiency; Hereditary hemochromatosis; Early-onset primary dystonia

• AncestryDNA: Factor V Leiden (hereditary thrombophilia)

  K192944 · 510(k) cleared Aug 13, 2020 · Ancestry Genomics

  Hereditary thrombophilia (Factor V Leiden)

• Helix: Late-onset Alzheimer's disease (APOE)

  K192073 · 510(k) cleared Dec 23, 2020 · Helix

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• GlutenID: Celiac disease (HLA-DQ)

  K241456 · 510(k) cleared Jan 7, 2025 · Targeted Genomics

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About genetic health risk tests · All FDA records