Cancer predisposition · 510(k) K223597

23andMe: BRCA1/BRCA2, 44 selected variants

FDA record K223597: 510(k) cleared on August 31, 2023 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 recordK223597

FDA device name

23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)

Applicant (as FDA lists it)

23AndMe, Inc.

FDA decision

Substantially equivalent (cleared)

Decision date

August 31, 2023 (received Dec 2, 2022)

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 the reporting of the following 44 variants in the BRCA1 and BRCA2 genes.

The report describes if a person’s genetic result is associated with an increased risk of developing breast cancer and ovarian cancer and may be associated with an increased risk for prostate cancer, pancreatic cancer, and potentially other cancers.

Genes or markers named: BRCA1, BRCA2

Stated limitations

The variants included in this report do not represent the majority of the BRCA1/BRCA2 variants in people of most ethnicities.

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)

Other cancer predisposition records

• 23andMe: BRCA1/BRCA2, three selected variants

  DEN170046 · De Novo request granted Mar 6, 2018 · 23andMe

  Breast cancer risk (BRCA1/BRCA2); Ovarian cancer risk (BRCA1/BRCA2); Prostate cancer risk (BRCA1/BRCA2)

• 23andMe: MUTYH-associated polyposis

  K182784 · 510(k) cleared Jan 18, 2019 · 23andMe

  Colorectal cancer risk (MUTYH-associated polyposis)

• 23andMe: Hereditary prostate cancer (HOXB13)

  K211499 · 510(k) cleared Jan 6, 2022 · 23andMe

  Prostate cancer risk (HOXB13)

About cancer predisposition tests · All FDA records