Genetic health risk · 510(k) K192073

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

FDA record K192073: 510(k) cleared on December 23, 2020 for Helix. It was decided after FDA last updated its Direct-to-Consumer Tests table (December 20, 2019); it appears in FDA's device database.

FDA recordK192073

FDA device name

Helix Genetic Health Risk App for late-onset Alzheimer’s disease (text repaired: openFDA returns a Windows-1252 character as a control code)

Applicant (as FDA lists it)

Helix Opco, LLC

FDA decision

Substantially equivalent (cleared)

Decision date

December 23, 2020 (received Aug 2, 2019)

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

The Helix Genetic Health Risk App (HRA) for late-onset Alzheimer’s disease is indicated for reporting of the e2/e2, e2/e3, e3/e3, e2/e4, e3/e4 and e4/e4 genotypes in the APOE gene.

The report describes if a person's genetic result is associated with an increased or decreased risk of developing late-onset Alzheimer’s disease.

Genes or markers named: APOE

Stated limitations

This test is not intended to diagnose a disease, determine medical treatment or other medical intervention, or tell the user anything about their current state of health.

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)

Also in the FDA file

The Helix Genetic Health Risk App (HRA) is to be used with the Helix Laboratory Platform.

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)

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