Genetic health risk · 510(k) K192944

AncestryDNA: Factor V Leiden (hereditary thrombophilia)

FDA record K192944: 510(k) cleared on August 13, 2020 for Ancestry Genomics. It was decided after FDA last updated its Direct-to-Consumer Tests table (December 20, 2019); it appears in FDA's device database.

FDA recordK192944

FDA device name

AncestryDNA Factor V Leiden Genetic Health Risk Test

Applicant (as FDA lists it)

Ancestry Genomics, Inc.

FDA decision

Substantially equivalent (cleared)

Decision date

August 13, 2020 (received Oct 18, 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 AncestryDNA Factor V Leiden Genetic Health Risk Report for Hereditary Thrombophilia is indicated for reporting of the Factor V Leiden variant in the F5 gene. This report describes if a person has variants associated with a higher risk of developing harmful blood clots, but it does not describe a person's overall risk of developing harmful blood clots.

This test is most relevant for people of European descent.

Genes or markers named: F5

Stated limitations

The test does not diagnose any specific health conditions. Results should not be used to make medical decisions.

The probability that the laboratory cannot process a sample can be up to 3%

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

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• GlutenID: Celiac disease (HLA-DQ)

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About genetic health risk tests · All FDA records