FDA authorizations under four direct-to-consumer genetic test product codes

Thirteen records from FDA's 510(k) and De Novo databases under the four product codes FDA uses for direct-to-consumer genetic health risk, cancer predisposition, carrier screening and pharmacogenetic tests (PTA, QAZ, PKB and QDJ), as of September 28, 2026. Listed by decision date. No rankings.

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Comparison table

Timeline

1. Feb 19, 2015
   23andMe: Bloom syndrome carrier status (De Novo DEN140044)
2. Apr 6, 2017
   23andMe: Ten genetic health risk reports (De Novo DEN160026)
3. Mar 6, 2018
   23andMe: BRCA1/BRCA2, three selected variants (De Novo DEN170046)
4. Oct 31, 2018
   23andMe: Pharmacogenetic reports, eight genes (De Novo DEN180028)
5. Jan 18, 2019
   23andMe: MUTYH-associated polyposis (510(k) K182784)
6. Aug 13, 2020
   AncestryDNA: Factor V Leiden (hereditary thrombophilia) (510(k) K192944)
7. Aug 17, 2020
   23andMe: CYP2C19 report with drug information (510(k) K193492)
8. Dec 23, 2020
   Helix: Late-onset Alzheimer's disease (APOE) (510(k) K192073)
9. Jan 6, 2022
   23andMe: Hereditary prostate cancer (HOXB13) (510(k) K211499)
10. Oct 26, 2022
    23andMe: SLCO1B1 report with drug information (510(k) K221885)
11. Oct 27, 2022
    AlphaID: Alpha-1 antitrypsin deficiency, 14 variants (510(k) K221420)
12. Aug 31, 2023
    23andMe: BRCA1/BRCA2, 44 selected variants (510(k) K223597)
13. Jan 7, 2025
    GlutenID: Celiac disease (HLA-DQ) (510(k) K241456)

By test type

• Carrier screening

  Exempt from premarket notification, with conditions

  “Carrier screening tests are exempt from FDA premarket review, but they do need to follow specific requirements that are described in the regulation for this type of test.” (U.S. Food and Drug Administration)

  One FDA record under PKB. Conditions and details

• Genetic health risk

  First test reviewed; later tests exempt, with conditions

  “Companies that offer DTC GHR tests are required to obtain FDA clearance prior to offering their first test. Companies may then offer most additional DTC GHR tests without FDA premarket review, provided they meet specific requirements that are described in the regulation for this type of test and are not for specific higher risk uses.” (U.S. Food and Drug Administration)

  Five FDA records under PTA. Conditions and details

• Cancer predisposition

  FDA reviews before sale

  “These tests are considered moderate to high risk and are required to come to FDA for premarket review and clearance.” (U.S. Food and Drug Administration)

  Four FDA records under QAZ. Conditions and details

• Pharmacogenetics

  FDA reviews before sale

  “Companies that offer DTC pharmacogenetic tests are required to come to FDA for premarket review and clearance.” (U.S. Food and Drug Administration)

  Three FDA records under QDJ. Conditions and details

• Ancestry

  Not reviewed by FDA

  “Some tests are used to help individuals explore their genetic ancestry. The FDA does not review these types of tests.” (U.S. Food and Drug Administration)

  No FDA records to list. Conditions and details

• Wellness and traits

  Generally not reviewed by FDA

  “Some tests are offered for purposes the FDA considers general wellness, such as tests that predict athletic ability. The FDA generally does not review low risk general wellness products.” (U.S. Food and Drug Administration)

  No FDA records to list. Conditions and details

openFDA queries behind this list: PTA (5), QAZ (4), PKB (1), QDJ (3). Data last updated September 28, 2026. Download the frozen dataset.