At-Home DNA Tests

Cancer predisposition · 510(k) K211499

23andMe: Hereditary prostate cancer (HOXB13)

FDA record K211499: 510(k) cleared on January 6, 2022 for 23andMe. It was decided after FDA last updated its Direct-to-Consumer Tests table (December 20, 2019); it appears in FDA's device database.

FDA recordK211499
FDA device name
23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
Applicant (as FDA lists it)
23AndMe, Inc.
FDA decision
Substantially equivalent (cleared)
Decision date
January 6, 2022 (received May 14, 2021)
Product code
QAZ
Regulation
21 CFR 866.6090

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

What the authorization says it may report

is indicated for reporting of the G84E variant in the HOXB13 gene. The report describes if a person has the G84E variant and if a male is at increased risk for prostate cancer. The variant included in this report is most common in people of European descent.

Genes or markers named: HOXB13

Stated limitations

The test report does not describe a person's overall risk of developing any type of cancer, and the absence of a variant tested does not rule out the presence of other variants that may be cancer-related.

FDA classifies this test type under 21 CFR 866.6090, which says: “This assessment system is for over-the-counter use. This device does not determine the person's overall risk of developing any types of cancer.” (21 CFR 866.6090)

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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