{
 "title": "FDA marketing authorizations for direct-to-consumer genetic tests (US)",
 "collected": "2026-10-12",
 "openfda_last_updated": "2026-09-28",
 "scope": "Every openFDA device record under product codes PTA (genetic health risk), QAZ (cancer predisposition risk), PKB (autosomal recessive carrier screening) and QDJ (direct-to-consumer access pharmacogenetic assessment). Quotes are verbatim from FDA, eCFR, NIH, EEOC, HHS-OIG, FTC and NSGC pages; FTC pages are read from Internet Archive copies because ftc.gov refuses automated requests.",
 "product_code_queries": [
  "https://api.fda.gov/device/510k.json?search=product_code:PTA&limit=100",
  "https://api.fda.gov/device/510k.json?search=product_code:QAZ&limit=100",
  "https://api.fda.gov/device/510k.json?search=product_code:PKB&limit=100",
  "https://api.fda.gov/device/510k.json?search=product_code:QDJ&limit=100"
 ],
 "query_totals": {
  "PTA": 5,
  "QAZ": 4,
  "PKB": 1,
  "QDJ": 3
 },
 "text_fixes": "device_name/sponsor: Windows-1252 characters that openFDA returns as C1 control codes are mapped back (for example U+0092 to ’, U+0099 to ™); the original string is kept in device_name_raw / sponsor_raw.",
 "sources": {
  "fda_dtc": {
   "url": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
   "publisher": "U.S. Food and Drug Administration",
   "title": "Direct-to-Consumer Tests",
   "note": "Page says “Content current as of: 12/20/2019”."
  },
  "ecfr_5950": {
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-866/subpart-F/section-866.5950",
   "publisher": "eCFR (Office of the Federal Register)",
   "title": "21 CFR 866.5950 Genetic health risk assessment system"
  },
  "ecfr_5940": {
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-866/subpart-F/section-866.5940",
   "publisher": "eCFR (Office of the Federal Register)",
   "title": "21 CFR 866.5940 Autosomal recessive carrier screening gene mutation detection system"
  },
  "ecfr_3364": {
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-862/subpart-D/section-862.3364",
   "publisher": "eCFR (Office of the Federal Register)",
   "title": "21 CFR 862.3364 Pharmacogenetic assessment system"
  },
  "ecfr_6090": {
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-866/subpart-G/section-866.6090",
   "publisher": "eCFR (Office of the Federal Register)",
   "title": "21 CFR 866.6090 Cancer predisposition risk assessment system"
  },
  "genome_privacy": {
   "url": "https://www.genome.gov/about-genomics/policy-issues/Privacy",
   "publisher": "National Human Genome Research Institute (NIH)",
   "title": "Privacy in Genomics"
  },
  "genome_gina": {
   "url": "https://www.genome.gov/about-genomics/policy-issues/Genetic-Discrimination",
   "publisher": "National Human Genome Research Institute (NIH)",
   "title": "Genetic Discrimination"
  },
  "eeoc_gina": {
   "url": "https://www.eeoc.gov/genetic-information-discrimination",
   "publisher": "U.S. Equal Employment Opportunity Commission",
   "title": "Genetic Information Discrimination"
  },
  "medline_what": {
   "url": "https://medlineplus.gov/genetics/understanding/dtcgenetictesting/directtoconsumer/",
   "publisher": "MedlinePlus Genetics (National Library of Medicine)",
   "title": "What is direct-to-consumer genetic testing?"
  },
  "medline_pros": {
   "url": "https://medlineplus.gov/genetics/understanding/dtcgenetictesting/dtcrisksbenefits/",
   "publisher": "MedlinePlus Genetics (National Library of Medicine)",
   "title": "What are the pros and cons of direct-to-consumer genetic testing?"
  },
  "ftc_holiday": {
   "url": "https://consumer.ftc.gov/consumer-alerts/2023/12/if-dna-test-kits-are-your-holiday-shopping-list",
   "archive": "https://web.archive.org/web/20260513204740/https://consumer.ftc.gov/consumer-alerts/2023/12/if-dna-test-kits-are-your-holiday-shopping-list",
   "archived": "2026-05-13",
   "publisher": "Federal Trade Commission",
   "title": "If DNA test kits are on your holiday shopping list (Consumer Alert, December 19, 2023)"
  },
  "ftc_keep": {
   "url": "https://consumer.ftc.gov/consumer-alerts/2023/06/keep-peoples-sensitive-dna-information-private",
   "archive": "https://web.archive.org/web/20260616121909/https://consumer.ftc.gov/consumer-alerts/2023/06/keep-peoples-sensitive-dna-information-private",
   "archived": "2026-06-16",
   "publisher": "Federal Trade Commission",
   "title": "Keep people’s sensitive DNA information private (Consumer Alert, June 16, 2023)"
  },
  "ftc_1health": {
   "url": "https://www.ftc.gov/news-events/news/press-releases/2023/06/ftc-says-genetic-testing-company-1health-failed-protect-privacy-security-dna-data-unfairly-changed",
   "archive": "https://web.archive.org/web/20260930014806/https://www.ftc.gov/news-events/news/press-releases/2023/06/ftc-says-genetic-testing-company-1health-failed-protect-privacy-security-dna-data-unfairly-changed",
   "archived": "2026-09-30",
   "publisher": "Federal Trade Commission",
   "title": "FTC Says Genetic Testing Company 1Health Failed to Protect Privacy and Security of DNA Data (press release, June 16, 2023)"
  },
  "ftc_23andme": {
   "url": "https://www.ftc.gov/news-events/news/press-releases/2025/03/federal-trade-commission-chairman-andrew-n-ferguson-issues-letter-23andme-bankruptcy-impact",
   "archive": "https://web.archive.org/web/20260622132734/https://www.ftc.gov/news-events/news/press-releases/2025/03/federal-trade-commission-chairman-andrew-n-ferguson-issues-letter-23andme-bankruptcy-impact",
   "archived": "2026-06-22",
   "publisher": "Federal Trade Commission",
   "title": "FTC Chairman Issues Letter on 23andMe Bankruptcy Impact to Consumers (press release, March 31, 2025)"
  },
  "ecfr_8669": {
   "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-866/subpart-A/section-866.9",
   "publisher": "eCFR (Office of the Federal Register)",
   "title": "21 CFR 866.9 Limitations of exemptions from section 510(k)"
  },
  "ecfr_160102": {
   "url": "https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-160/subpart-A/section-160.102",
   "publisher": "eCFR (Office of the Federal Register)",
   "title": "45 CFR 160.102 Applicability (HIPAA rules)"
  },
  "ecfr_160103": {
   "url": "https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-160/subpart-A/section-160.103",
   "publisher": "eCFR (Office of the Federal Register)",
   "title": "45 CFR 160.103 Definitions (HIPAA rules)"
  },
  "eeoc_statute": {
   "url": "https://www.eeoc.gov/statutes/genetic-information-nondiscrimination-act-2008",
   "publisher": "U.S. Equal Employment Opportunity Commission",
   "title": "Genetic Information Nondiscrimination Act of 2008 (statute text, Title II)"
  },
  "oig_scam": {
   "url": "https://oig.hhs.gov/fraud/consumer-alerts/fraud-alert-genetic-testing-scam/",
   "publisher": "HHS Office of Inspector General",
   "title": "Fraud Alert: Genetic Testing Scam"
  },
  "nsgc_find": {
   "url": "https://findageneticcounselor.nsgc.org/",
   "publisher": "National Society of Genetic Counselors",
   "title": "Find a Genetic Counselor"
  }
 },
 "citations": {
  "dtcDefined": {
   "source": "fda_dtc",
   "quote": "In vitro diagnostics (IVDs) that are marketed directly to consumers without the involvement of a health care provider are called direct-to-consumer tests (also referred to as DTC)."
  },
  "someReviewed": {
   "source": "fda_dtc",
   "quote": "Some direct-to-consumer tests are reviewed by the FDA while others are not."
  },
  "lowRiskNot": {
   "source": "fda_dtc",
   "quote": "In general, direct-to-consumer tests for non-medical, general wellness, or low risk medical purposes are not reviewed by the FDA before they are offered."
  },
  "modHighYes": {
   "source": "fda_dtc",
   "quote": "Direct-to-consumer tests for moderate to high risk medical purposes, which may have a higher impact on medical care, are generally reviewed by the FDA to determine the validity of test claims."
  },
  "listEvaluated": {
   "source": "fda_dtc",
   "quote": "The direct-to-consumer tests listed below have undergone an evaluation by the FDA for accuracy, reliability, and consumer comprehension."
  },
  "pageDate": {
   "source": "fda_dtc",
   "quote": "12/20/2019"
  },
  "carrierWhat": {
   "source": "fda_dtc",
   "quote": "These tests can be used to determine whether a healthy person carries a genetic variant that could be passed on to their potential future child(ren)."
  },
  "carrierOdds": {
   "source": "fda_dtc",
   "quote": "These tests are for disorders where two copies of an abnormal gene variant must be present for the disease or condition to develop, meaning that each parent has one copy of the abnormal variant that could be passed on, giving the child a 25% chance of developing the disease or condition."
  },
  "carrierExempt": {
   "source": "fda_dtc",
   "quote": "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."
  },
  "ghrWhat": {
   "source": "fda_dtc",
   "quote": "GHR tests are intended to provide information on an individual's genetic risk for certain medical diseases or conditions."
  },
  "ghrNotOverall": {
   "source": "fda_dtc",
   "quote": "The GHR tests are intended to provide genetic risk information to consumers, but these tests do not determine a person's overall risk of developing a disease or condition."
  },
  "ghrFirst": {
   "source": "fda_dtc",
   "quote": "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."
  },
  "pgxWhat": {
   "source": "fda_dtc",
   "quote": "Pharmacogenetics tests provide information regarding the role genetics may play in an individual's reaction to drugs."
  },
  "pgxReview": {
   "source": "fda_dtc",
   "quote": "Companies that offer DTC pharmacogenetic tests are required to come to FDA for premarket review and clearance."
  },
  "pgxNone": {
   "source": "fda_dtc",
   "quote": "Currently the FDA has not authorized any DTC pharmacogenetic tests that predict whether an individual is likely to respond to or have adverse reactions from any specific therapeutic drug."
  },
  "cancerWhat": {
   "source": "fda_dtc",
   "quote": "These tests provide information about an individual's risk of getting certain types of cancer."
  },
  "cancerReview": {
   "source": "fda_dtc",
   "quote": "These tests are considered moderate to high risk and are required to come to FDA for premarket review and clearance."
  },
  "wellness": {
   "source": "fda_dtc",
   "quote": "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."
  },
  "ancestry": {
   "source": "fda_dtc",
   "quote": "Some tests are used to help individuals explore their genetic ancestry. The FDA does not review these types of tests."
  },
  "negative": {
   "source": "fda_dtc",
   "quote": "it is important that consumers understand that a negative result means they still may be at risk for a particular disease or condition."
  },
  "differentCos": {
   "source": "fda_dtc",
   "quote": "Not all direct-to-consumer genetic test companies test for the same set of variants, and therefore may provide different results for the same disease or condition."
  },
  "notAccurate": {
   "source": "fda_dtc",
   "quote": "No test is 100% accurate."
  },
  "positive": {
   "source": "fda_dtc",
   "quote": "Remember that a positive result from a test does not mean that you will develop that disease or condition."
  },
  "counselor": {
   "source": "fda_dtc",
   "quote": "For genetic tests, you may also consider speaking with a genetic counselor, board-certified medical geneticist, or other equivalent health care provider."
  },
  "noDecisions": {
   "source": "fda_dtc",
   "quote": "Do not make any dietary or health-related decisions without first discussing your test results with your health care provider."
  },
  "fdaGinaGap": {
   "source": "fda_dtc",
   "quote": "Receiving a genetic testing result may impact your purchase of life, disability, and long-term care insurance."
  },
  "medwatch": {
   "source": "fda_dtc",
   "quote": "Problems should be reported both to the FDA and the company whenever a consumer suspects that there is an issue with a direct-to-consumer test."
  },
  "cfrGhr": {
   "source": "ecfr_5950",
   "quote": "This assessment system is for over-the-counter use. This device does not determine the person's overall risk of developing a disease."
  },
  "cfrGhrDifferent": {
   "source": "ecfr_5950",
   "quote": "other companies offering a genetic risk test may be detecting different genetic variants for the same disease, so the user may get different results using a test from a different company."
  },
  "cfrGhrAnxious": {
   "source": "ecfr_5950",
   "quote": "some people may feel anxious about getting genetic test health results. This is normal."
  },
  "cfrGhrCounselor": {
   "source": "ecfr_5950",
   "quote": "Information about how to obtain access to a genetic counselor, board-certified clinical molecular geneticist, or equivalent health care professional about the results of a user's test."
  },
  "cfrCarrier": {
   "source": "ecfr_5940",
   "quote": "Autosomal recessive carrier screening gene mutation detection system is a qualitative in vitro molecular diagnostic system used for genotyping of clinically relevant variants in genomic DNA isolated from human specimens intended for prescription use or over-the-counter use. The device is intended for autosomal recessive disease carrier screening in adults of reproductive age. The device is not intended for copy number variation, cytogenetic, or biochemical testing."
  },
  "cfrCarrierExempt": {
   "source": "ecfr_5940",
   "quote": "The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9, except § 866.9(c)(2). Autosomal recessive carrier screening gene mutation detection system must comply with the following special controls:"
  },
  "cfrGhrExempt": {
   "source": "ecfr_5950",
   "quote": "The genetic health risk assessment system device, when it has previously received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the genetic health risk assessment system (a “one-time FDA reviewed genetic health risk assessment system”), is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 866.9. The device must comply with the following special controls:"
  },
  "cfrGhrOptIn": {
   "source": "ecfr_5950",
   "quote": "When the test reports the risk of a life-threatening or irreversibly debilitating disease or condition for which there are few or no options to prevent, treat, or cure the disease, a user opt-in section must be provided."
  },
  "cfr8669": {
   "source": "ecfr_8669",
   "quote": "The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality."
  },
  "cfr8669c2": {
   "source": "ecfr_8669",
   "quote": "For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;"
  },
  "hipaaApplies": {
   "source": "ecfr_160102",
   "quote": "the standards, requirements, and implementation specifications adopted under this subchapter apply to the following entities: (1) A health plan. (2) A health care clearinghouse. (3) A health care provider who transmits any health information in electronic form in connection with a transaction covered by this subchapter."
  },
  "hipaaBA": {
   "source": "ecfr_160102",
   "quote": "Where provided, the standards, requirements, and implementation specifications adopted under this subchapter apply to a business associate."
  },
  "hipaaBADef": {
   "source": "ecfr_160103",
   "quote": "creates, receives, maintains, or transmits protected health information for a function or activity regulated by this subchapter"
  },
  "cfrPgx": {
   "source": "ecfr_3364",
   "quote": "A pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system intended to detect nucleic acid variants isolated from human specimens for the purpose of assessing the presence of genetic variants that impact the metabolism, exposure, response, risk of adverse events, dosing, or mechanisms of prescription or over-the-counter medications."
  },
  "cfrCancer": {
   "source": "ecfr_6090",
   "quote": "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."
  },
  "noFederalLaw": {
   "source": "genome_privacy",
   "quote": "While many companies have robust privacy and informed consent policies, no federal laws prohibit companies from providing individuals’ genetic information to third parties."
  },
  "ftcRole": {
   "source": "genome_privacy",
   "quote": "the Federal Trade Commission provides some protections and can take enforcement action against companies that make false or misleading statements regarding data privacy and security or companies that fail to protect individuals’ information."
  },
  "uploadRisk": {
   "source": "genome_privacy",
   "quote": "Importantly, if an individual chooses to download their genetic information from one of these services or upload it to another, the company that originally collected the data is no longer responsible for any breach of privacy that may occur."
  },
  "hipaaWhat": {
   "source": "genome_privacy",
   "quote": "Privacy Rule protects the confidentiality of patients’ individually identifiable health information — or Protected Health Information (PHI) — that HIPAA-covered entities (e.g., health care providers or an insurance company) hold."
  },
  "hipaaGenetic": {
   "source": "genome_privacy",
   "quote": "the Privacy Rule was modified to establish that genetic information is considered PHI"
  },
  "ginaBoth": {
   "source": "genome_gina",
   "quote": "The Genetic Information Nondiscrimination Act (GINA) of 2008 protects Americans from discrimination based on their genetic information in both health insurance (Title I) and employment (Title II)."
  },
  "ginaInsurers": {
   "source": "genome_gina",
   "quote": "health insurers may not use genetic information to determine if someone is eligible for insurance or to make coverage, underwriting or premium-setting decisions."
  },
  "ginaGaps": {
   "source": "genome_gina",
   "quote": "GINA’s health insurance protections do not cover long-term care insurance, life insurance, or disability insurance"
  },
  "ginaSmall": {
   "source": "genome_gina",
   "quote": "GINA does not apply to employers with fewer than 15 employees."
  },
  "ginaMilitary": {
   "source": "genome_gina",
   "quote": "The military is permitted to use genetic information to make employment decisions."
  },
  "eeocTitle2": {
   "source": "eeoc_gina",
   "quote": "Title II of GINA prohibits the use of genetic information in making employment decisions, restricts employers and other entities covered by Title II (employment agencies, labor organizations and joint labor-management training and apprenticeship programs - referred to as \"covered entities\") from requesting, requiring or purchasing genetic information, and strictly limits the disclosure of genetic information."
  },
  "eeocTitle1": {
   "source": "eeoc_gina",
   "quote": "The Departments of Labor, Health and Human Services and the Treasury have responsibility for issuing regulations for Title I of GINA, which addresses the use of genetic information in health insurance."
  },
  "eeocFamily": {
   "source": "eeoc_gina",
   "quote": "Genetic information includes information about an individual's genetic tests and the genetic tests of an individual's family members, as well as information about the manifestation of a disease or disorder in an individual's family members (i.e. family medical history)."
  },
  "ginaManifest": {
   "source": "eeoc_statute",
   "quote": "shall not be considered to be in violation of this title based on the use, acquisition, or disclosure of medical information that is not genetic information about a manifested disease, disorder, or pathological condition of an employee or member, including a manifested disease, disorder, or pathological condition that has or may have a genetic basis."
  },
  "ginaRequest": {
   "source": "genome_gina",
   "quote": "health insurers may not request or require individuals or their family members to undergo genetic testing or to provide genetic information."
  },
  "eeocNever": {
   "source": "eeoc_gina",
   "quote": "An employer may never use genetic information to make an employment decision because genetic information is not relevant to an individual's current ability to work."
  },
  "medlineConfirm": {
   "source": "medline_what",
   "quote": "additional testing through a healthcare provider is usually required before direct-to-consumer test results can be used to diagnose a medical condition or make healthcare decisions."
  },
  "medlineCost": {
   "source": "medline_what",
   "quote": "The cost of direct-to-consumer genetic testing is generally not covered by most health insurance plans."
  },
  "medlineRecord": {
   "source": "medline_pros",
   "quote": "The results are provided directly to you and are not placed in your medical record (unless you share the results with your healthcare provider)."
  },
  "medlineBankrupt": {
   "source": "medline_pros",
   "quote": "if a direct-to-consumer genetic testing company changes ownership, goes out of business, or declares bankruptcy, your genetic information may be transferred or sold."
  },
  "medlinePolice": {
   "source": "medline_pros",
   "quote": "Direct-to-consumer genetic testing companies may be required to disclose genetic information to law enforcement officials."
  },
  "medlineFamily": {
   "source": "medline_pros",
   "quote": "Because relatives share genetic information, your results may have implications for other members of your family."
  },
  "medlineUpsetting": {
   "source": "medline_pros",
   "quote": "Receiving unexpected information about your health, family relationships, or ancestry may be upsetting."
  },
  "ftcPromises": {
   "source": "ftc_holiday",
   "quote": "Take a close look at the company’s privacy promises."
  },
  "ftcShare": {
   "source": "ftc_holiday",
   "quote": "Do they share users’ information with other companies?"
  },
  "ftcDelete": {
   "source": "ftc_holiday",
   "quote": "Can you delete your information if you want to?"
  },
  "ftcPassword": {
   "source": "ftc_holiday",
   "quote": "They’ll need a strong password they haven’t used on any other website."
  },
  "ftcDefaults": {
   "source": "ftc_holiday",
   "quote": "Don’t just settle for out-of-the-box defaults. They may not offer the most protection."
  },
  "ftcRelatives": {
   "source": "ftc_holiday",
   "quote": "It tells a story not just about you, but also about people you’re related to."
  },
  "ftcHacks": {
   "source": "ftc_holiday",
   "quote": "Even if a company promises not to share data with others, hack attacks still happen."
  },
  "ftcTerms": {
   "source": "ftc_keep",
   "quote": "Read and understand the company’s “terms of use” before you buy."
  },
  "ftcRetro": {
   "source": "ftc_1health",
   "quote": "The FTC Act prohibits companies from unilaterally applying material privacy policy changes to previously collected data."
  },
  "ftcBuckets": {
   "source": "ftc_1health",
   "quote": "nearly 2,400 health reports about consumers and raw genetic data of at least 227 consumers"
  },
  "ftc23andme": {
   "source": "ftc_23andme",
   "quote": "Consumers should be able to trust that companies will keep their promises, including when it comes to handling of sensitive information."
  },
  "ftc23andmeWhat": {
   "source": "ftc_23andme",
   "quote": "expressing the concerns American consumers have with the potential sale or transfer of their 23andMe data."
  },
  "oigMailed": {
   "source": "oig_scam",
   "quote": "If a genetic testing kit is mailed to you, don't accept it unless it was ordered by your physician."
  },
  "oigFree": {
   "source": "oig_scam",
   "quote": "Be suspicious of anyone who offers you \"free\" genetic testing and then requests your Medicare number."
  },
  "nsgcCount": {
   "source": "nsgc_find",
   "quote": "The Find a Genetic Counselor directory offers access to over 3,300 genetic counselors (US and Canada)."
  },
  "nsgcNotReferral": {
   "source": "nsgc_find",
   "quote": "The NSGC Find A Counselor directory is not a referral service"
  }
 },
 "records": [
  {
   "submission": "DEN140044",
   "pathway": "De Novo",
   "decision": "De Novo request granted",
   "decision_date": "2015-02-19",
   "date_received": "2014-05-29",
   "sponsor": "23AndMe",
   "device_name": "23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)",
   "product_code": "PKB",
   "category": "carrier-screening",
   "regulation": "21 CFR 866.5940",
   "on_fda_dtc_list": true,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN140044",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN140044.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:DEN140044",
   "short": "Bloom syndrome carrier status",
   "topics": [
    "Bloom syndrome"
   ],
   "genes": [
    "BLM"
   ],
   "reports": [
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "This test can be used to determine carrier status for Bloom syndrome in adults of reproductive age, but cannot determine if a person has two copies of the BLMAsh variant."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The test is most relevant for people of Ashkenazi Jewish descent."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN140044.pdf",
     "quote": "This test is not intended to diagnose a disease, to tell you anything about the health of your fetus, or your risk or your new born child’s risk of developing a particular disease later on in life."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN140044.pdf",
     "quote": "The probability that the laboratory cannot process the sample can be up to 7.6%."
    }
   ],
   "notes": []
  },
  {
   "submission": "DEN160026",
   "pathway": "De Novo",
   "decision": "De Novo request granted",
   "decision_date": "2017-04-06",
   "date_received": "2016-06-28",
   "sponsor": "23AndMe, Inc.",
   "device_name": "23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia",
   "product_code": "PTA",
   "category": "genetic-health-risk",
   "regulation": "21 CFR 866.5950",
   "on_fda_dtc_list": true,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN160026",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160026.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:DEN160026",
   "short": "Ten genetic health risk reports",
   "topics": [
    "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"
   ],
   "genes": [
    "F5",
    "F2",
    "SERPINA1",
    "APOE",
    "LRRK2",
    "GBA",
    "F11",
    "HLA-DQ2.5",
    "G6PD",
    "HFE",
    "DYT1/TOR1A"
   ],
   "reports": [
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The 23andMe PGS Genetic Health Risk Report for Hereditary Thrombophilia is indicated for reporting of the Factor V Leiden variant in the F5 gene, and the Prothrombin G20210A variant in the F2 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."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The 23andMe PGS Genetic Health Risk Report for Alpha-1 Antitrypsin Deficiency is indicated for reporting of the PI*Z and PI*S variants in the SERPINA1 gene. This report describes if a person has variants associated with AAT deficiency and a higher risk for lung or liver disease, but it does not describe a person's overall risk of developing lung or liver disease. This test is most relevant for people of European descent."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The 23andMe PGS Genetic Health Risk Report for Late-onset Alzheimer's Disease is indicated for reporting of the ε4 variant in the APOE gene. The report describes if a person's genetic result is associated with an increased risk of developing Late-onset Alzheimer's Disease, but it does not describe a person's overall risk of developing Alzheimer's Disease."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The 23andMe PGS Genetic Health Risk Report for Parkinson's Disease is indicated for reporting of the G2019S variant in the LRRK2 gene and the N370S variant in the GBA gene. The report describes if a person's genetic result is associated with an increased risk of developing Parkinson's disease, but it does not describe a person's overall risk of developing Parkinson's disease. The test is most relevant for people of European, Ashkenazi Jewish, and North African Berber descent."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The 23andMe PGS Genetic Health Risk Report for Gaucher Disease Type 1 is indicated for reporting of the N370S, 84GG, and V394L variants in the GBA gene. This report describes if a person has variants associated with an increased risk for developing symptoms of Gaucher Disease Type 1, but it does not describe a person's overall risk of developing Gaucher Disease Type 1. This test is most relevant for people of Ashkenazi Jewish descent."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The 23andMe PGS Genetic Health Risk Report for Factor XI Deficiency is indicated for reporting of the variants F283L, E117X, IVS14+1G>A in the F11 gene. This report describes if a person has a variant associated with Factor XI deficiency and the potential for a higher risk of excessive bleeding following trauma or surgery, but it does not describe a person's overall risk for excessive bleeding. This test is most relevant for people of Ashkenazi Jewish descent."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The 23andMe PGS Genetic Health Risk Report for Celiac Disease is indicated for reporting of a variant associated with the HLA-DQ2.5 haplotype. The report describes if a person has a haplotype associated with an increased risk of developing celiac disease, but it does not describe a person's overall risk for developing celiac disease. This report is most relevant for people of European descent."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The 23andMe PGS Genetic Health Risk Report for Glucose-6-Phosphate-Dehydrogenase Deficiency is indicated for reporting of the Val68Met variant in the G6PD gene. This report describes if a person has a variant associated with G6PD deficiency and a higher risk for episodes of anemia, but it does not describe a person's overall risk of developing anemia. This test is most relevant for people of African descent."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The 23andMe PGS Genetic Health Risk Report for Hereditary Hemochromatosis is indicated for reporting of the C282Y and H63D variants in the HFE gene. This report describes if a person has variants associated with hereditary hemochromatosis and a higher risk for iron overload, but it does not describe a person's overall risk of developing iron overload. This report is most relevant for people of European descent."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The 23andMe PGS Genetic Health Risk Report for Early-Onset Primary Dystonia (DYT1/TOR1A-Related) is indicated for reporting of the deltaE302/303 variant in the DYT1 gene. This report describes if a person has variants associated with a higher risk for early-onset primary dystonia, but it does not describe a person's overall risk of developing dystonia. This report is most relevant for people of Ashkenazi Jewish descent."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160026.pdf",
     "quote": "The test does not diagnose any specific health conditions. Results should not be used to make medical decisions."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160026.pdf",
     "quote": "The probability that the laboratory cannot process a sample can be up to 7.6%."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160026.pdf",
     "quote": "A user’s race, ethnicity, age, and sex may affect how the genetic test results are interpreted."
    }
   ],
   "notes": []
  },
  {
   "submission": "DEN170046",
   "pathway": "De Novo",
   "decision": "De Novo request granted",
   "decision_date": "2018-03-06",
   "date_received": "2017-09-05",
   "sponsor": "23AndMe, Inc.",
   "device_name": "23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)",
   "product_code": "QAZ",
   "category": "cancer-predisposition",
   "regulation": "21 CFR 866.6090",
   "on_fda_dtc_list": true,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN170046",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170046.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:DEN170046",
   "short": "BRCA1/BRCA2, three selected variants",
   "topics": [
    "Breast cancer risk (BRCA1/BRCA2)",
    "Ovarian cancer risk (BRCA1/BRCA2)",
    "Prostate cancer risk (BRCA1/BRCA2)"
   ],
   "genes": [
    "BRCA1",
    "BRCA2"
   ],
   "reports": [
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is indicated for reporting of the 185delAG and 5382insC variants in the BRCA1 gene and the 6174delT variant in the BRCA2 gene. The report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The three variants included in this report are most common in people of Ashkenazi Jewish descent and do not represent the majority of the BRCA1/BRCA2 variants in the general population."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170046.pdf",
     "quote": "There are more than 1,000 different BRCA1/BRCA2 variants known to be associated with increased risk of developing cancer."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170046.pdf",
     "quote": "Results should be confirmed in a clinical setting before taking any medical action."
    }
   ],
   "notes": []
  },
  {
   "submission": "DEN180028",
   "pathway": "De Novo",
   "decision": "De Novo request granted",
   "decision_date": "2018-10-31",
   "date_received": "2018-06-05",
   "sponsor": "23AndMe, Inc.",
   "device_name": "23andMe Personal Genome Service (PGS) Pharmacogenetic Reports",
   "product_code": "QDJ",
   "category": "pharmacogenetics",
   "regulation": "21 CFR 862.3364",
   "on_fda_dtc_list": true,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180028",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180028.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:DEN180028",
   "short": "Pharmacogenetic reports, eight genes",
   "topics": [
    "How the body processes some medications (CYP2C19, CYP2C9, CYP3A5, UGT1A1, DPYD, TPMT, SLCO1B1, CYP2D6)"
   ],
   "genes": [
    "CYP2C19",
    "CYP2C9",
    "CYP3A5",
    "UGT1A1",
    "DPYD",
    "TPMT",
    "SLCO1B1",
    "CYP2D6"
   ],
   "reports": [
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "This report describes if a person has variants associated with metabolism of some therapeutics, but does not describe if a person will or will not respond to a particular therapeutic, and does not describe the association between detected variants and any specific therapeutic."
    },
    {
     "src": "https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests",
     "quote": "The information provided by this report should not be used to start, stop, or change any course of treatment."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180028.pdf",
     "quote": "Results should be confirmed in a clinical setting with independent genetic testing before taking any medical action."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180028.pdf",
     "quote": "This test does not diagnose any health conditions, predict drug response, provide medical advice, or determine whether a medication is indicated for the user."
    }
   ],
   "notes": []
  },
  {
   "submission": "K182784",
   "pathway": "510(k)",
   "decision": "Substantially equivalent (cleared)",
   "decision_date": "2019-01-18",
   "date_received": "2018-10-01",
   "sponsor": "23AndMe, Inc.",
   "device_name": "MUTYH-Associated Polyposis (MAP)",
   "product_code": "QAZ",
   "category": "cancer-predisposition",
   "regulation": "21 CFR 866.6090",
   "on_fda_dtc_list": false,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K182784",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182784.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:K182784",
   "short": "MUTYH-associated polyposis",
   "topics": [
    "Colorectal cancer risk (MUTYH-associated polyposis)"
   ],
   "genes": [
    "MUTYH"
   ],
   "reports": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182784.pdf",
     "quote": "The 23andMe PGS Genetic Health Risk Report for MUTYH-Associated Polyposis is indicated for reporting of the Y179C and the G396D variants in the MUTYH gene. The report describes if a person is at increased risk of developing colorectal cancer."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182784.pdf",
     "quote": "The two variants included in this report are most common and best studied in people of Northern European descent and may not represent the majority of the MUTYH variants found in people of other ethnicities."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182784.pdf",
     "quote": "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."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182784.pdf",
     "quote": "the absence of a variant tested does not rule out the presence of other variants that may be cancer-related."
    }
   ],
   "notes": []
  },
  {
   "submission": "K192944",
   "pathway": "510(k)",
   "decision": "Substantially equivalent (cleared)",
   "decision_date": "2020-08-13",
   "date_received": "2019-10-18",
   "sponsor": "Ancestry Genomics, Inc.",
   "device_name": "AncestryDNA Factor V Leiden Genetic Health Risk Test",
   "product_code": "PTA",
   "category": "genetic-health-risk",
   "regulation": "21 CFR 866.5950",
   "on_fda_dtc_list": false,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K192944",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192944.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:K192944",
   "short": "Factor V Leiden (hereditary thrombophilia)",
   "topics": [
    "Hereditary thrombophilia (Factor V Leiden)"
   ],
   "genes": [
    "F5"
   ],
   "reports": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192944.pdf",
     "quote": "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."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192944.pdf",
     "quote": "This test is most relevant for people of European descent."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192944.pdf",
     "quote": "The test does not diagnose any specific health conditions. Results should not be used to make medical decisions."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192944.pdf",
     "quote": "The probability that the laboratory cannot process a sample can be up to 3%"
    }
   ],
   "notes": []
  },
  {
   "submission": "K193492",
   "pathway": "510(k)",
   "decision": "Substantially equivalent (cleared)",
   "decision_date": "2020-08-17",
   "date_received": "2019-12-17",
   "sponsor": "23AndMe, Inc.",
   "device_name": "23andMe Personal Genome Service (PGS) Pharmacogenetic Reports",
   "product_code": "QDJ",
   "category": "pharmacogenetics",
   "regulation": "21 CFR 862.3364",
   "on_fda_dtc_list": false,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K193492",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193492.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:K193492",
   "short": "CYP2C19 report with drug information",
   "topics": [
    "How the body processes some medications (CYP2C19: citalopram, clopidogrel)"
   ],
   "genes": [
    "CYP2C19"
   ],
   "reports": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193492.pdf",
     "quote": "23andMe Personal Genome Service pharmacogenetic reports for CYP2C19 describes if a person has variants associated with metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of the identified metabolizer phenotype on citalopram and clopidogrel therapy."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193492.pdf",
     "quote": "The information provided by this report should not be used to start, stop, or change any course of treatment."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193492.pdf",
     "quote": "This report does not determine if a person will or will not respond to a particular therapeutic."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193492.pdf",
     "quote": "This test does not provide interpretive drug information for the CYP2C19 *3/*17 heterozygous genotype."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193492.pdf",
     "quote": "Do not use your results to start, stop or change any course of treatment."
    }
   ],
   "notes": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193492.pdf",
     "quote": "to add one new indication describing interpretive drug information to two specific medications (citalopram and clopidogrel), as well as to remove the limitation language requiring confirmatory testing."
    }
   ]
  },
  {
   "submission": "K192073",
   "pathway": "510(k)",
   "decision": "Substantially equivalent (cleared)",
   "decision_date": "2020-12-23",
   "date_received": "2019-08-02",
   "sponsor": "Helix Opco, LLC",
   "device_name": "Helix Genetic Health Risk App for late-onset Alzheimer’s disease",
   "device_name_raw": "Helix Genetic Health Risk App for late-onset Alzheimer’s disease",
   "product_code": "PTA",
   "category": "genetic-health-risk",
   "regulation": "21 CFR 866.5950",
   "on_fda_dtc_list": false,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K192073",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192073.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:K192073",
   "short": "Late-onset Alzheimer's disease (APOE)",
   "topics": [
    "Late-onset Alzheimer's disease"
   ],
   "genes": [
    "APOE"
   ],
   "reports": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192073.pdf",
     "quote": "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."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192073.pdf",
     "quote": "The report describes if a person's genetic result is associated with an increased or decreased risk of developing late-onset Alzheimer’s disease."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192073.pdf",
     "quote": "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."
    }
   ],
   "notes": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192073.pdf",
     "quote": "The Helix Genetic Health Risk App (HRA) is to be used with the Helix Laboratory Platform."
    }
   ]
  },
  {
   "submission": "K211499",
   "pathway": "510(k)",
   "decision": "Substantially equivalent (cleared)",
   "decision_date": "2022-01-06",
   "date_received": "2021-05-14",
   "sponsor": "23AndMe, Inc.",
   "device_name": "23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)",
   "product_code": "QAZ",
   "category": "cancer-predisposition",
   "regulation": "21 CFR 866.6090",
   "on_fda_dtc_list": false,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K211499",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211499.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:K211499",
   "short": "Hereditary prostate cancer (HOXB13)",
   "topics": [
    "Prostate cancer risk (HOXB13)"
   ],
   "genes": [
    "HOXB13"
   ],
   "reports": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211499.pdf",
     "quote": "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."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211499.pdf",
     "quote": "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."
    }
   ],
   "notes": []
  },
  {
   "submission": "K221885",
   "pathway": "510(k)",
   "decision": "Substantially equivalent (cleared)",
   "decision_date": "2022-10-26",
   "date_received": "2022-06-29",
   "sponsor": "23AndMe, Inc.",
   "device_name": "23andMe Personal Genome Service (PGS) Pharmacogenetic Reports",
   "product_code": "QDJ",
   "category": "pharmacogenetics",
   "regulation": "21 CFR 862.3364",
   "on_fda_dtc_list": false,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K221885",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221885.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:K221885",
   "short": "SLCO1B1 report with drug information",
   "topics": [
    "How the body processes some medications (SLCO1B1: simvastatin; CYP2C19: citalopram, clopidogrel)"
   ],
   "genes": [
    "SLCO1B1",
    "CYP2C19",
    "CYP2C9",
    "CYP3A5",
    "UGT1A1",
    "DPYD",
    "TPMT",
    "CYP2D6"
   ],
   "reports": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221885.pdf",
     "quote": "The 23andMe Personal Genome Service pharmacogenetic reports for CYP2C9, CYP3A5, UGT1A1, DPYD, TPMT and CYP2D6 describe if a person has variants associated with metabolism of some therapeutics but does not describe if a person will or will not respond to a particular therapeutic and does not describe the association between detected variants and any specific therapeutic."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221885.pdf",
     "quote": "23andMe Personal Genome Service pharmacogenetics report for CYP2C19 describes if a person has variants associated with metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of the identified metabolizer phenotype on citalopram and clopidogrel therapy."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221885.pdf",
     "quote": "23andMe Personal Genome Service pharmacogenetics report for SLCO1B1 describes if a person has variants associated with the processing of some therapeutics and provides interpretive drug information regarding the potential effect of the identified transport function phenotype on simvastatin therapy."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221885.pdf",
     "quote": "This test does not determine if a person will or will not respond to a particular therapeutic."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221885.pdf",
     "quote": "For CYP2C19 only: This test does not provide interpretive drug information for the CYP2C19 *3/*17 genotype or other CYP2C19 genotype combinations where the predicted metabolizer profile cannot be interpreted."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221885.pdf",
     "quote": "Do not use your results to start, stop or change any course of treatment."
    }
   ],
   "notes": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221885.pdf",
     "quote": "to provide interpretive drug information to one specific medication (simvastatin), and to remove the limitation language requiring confirmatory testing in the 23andMe pharmacogenetics report for SLCO1B1."
    }
   ]
  },
  {
   "submission": "K221420",
   "pathway": "510(k)",
   "decision": "Substantially equivalent (cleared)",
   "decision_date": "2022-10-27",
   "date_received": "2022-05-16",
   "sponsor": "Progenika Biopharma S.A., A Grifols Company",
   "device_name": "AlphaID™ At Home Genetic Health Risk Service",
   "device_name_raw": "AlphaID™ At Home Genetic Health Risk Service",
   "product_code": "PTA",
   "category": "genetic-health-risk",
   "regulation": "21 CFR 866.5950",
   "on_fda_dtc_list": false,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K221420",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221420.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:K221420",
   "short": "Alpha-1 antitrypsin deficiency, 14 variants",
   "topics": [
    "Alpha-1 antitrypsin deficiency"
   ],
   "genes": [
    "SERPINA1"
   ],
   "reports": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221420.pdf",
     "quote": "This Service is indicated for reporting 14 genetic variants in the SERPINA1 gene"
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221420.pdf",
     "quote": "The report describes if a person is at an increased risk of developing either lung and/or liver disease linked to AATD."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221420.pdf",
     "quote": "These 14 variants explain 95% of AATD cases."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221420.pdf",
     "quote": "The absence of a variant tested does not rule out the presence of other genetic variants that may be disease-related."
    }
   ],
   "notes": []
  },
  {
   "submission": "K223597",
   "pathway": "510(k)",
   "decision": "Substantially equivalent (cleared)",
   "decision_date": "2023-08-31",
   "date_received": "2022-12-02",
   "sponsor": "23AndMe, Inc.",
   "device_name": "23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)",
   "product_code": "QAZ",
   "category": "cancer-predisposition",
   "regulation": "21 CFR 866.6090",
   "on_fda_dtc_list": false,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K223597",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223597.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:K223597",
   "short": "BRCA1/BRCA2, 44 selected variants",
   "topics": [
    "Breast cancer risk (BRCA1/BRCA2)",
    "Ovarian cancer risk (BRCA1/BRCA2)",
    "Prostate cancer risk (BRCA1/BRCA2)",
    "Pancreatic cancer risk (BRCA1/BRCA2)"
   ],
   "genes": [
    "BRCA1",
    "BRCA2"
   ],
   "reports": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223597.pdf",
     "quote": "is indicated for the reporting of the following 44 variants in the BRCA1 and BRCA2 genes."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223597.pdf",
     "quote": "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."
    }
   ],
   "limits": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223597.pdf",
     "quote": "The variants included in this report do not represent the majority of the BRCA1/BRCA2 variants in people of most ethnicities."
    }
   ],
   "notes": []
  },
  {
   "submission": "K241456",
   "pathway": "510(k)",
   "decision": "Substantially equivalent (cleared)",
   "decision_date": "2025-01-07",
   "date_received": "2024-05-22",
   "sponsor": "Targeted Genomics, LLC",
   "device_name": "GlutenID Celiac Genetic Health Risk Test",
   "product_code": "PTA",
   "category": "genetic-health-risk",
   "regulation": "21 CFR 866.5950",
   "on_fda_dtc_list": false,
   "fda_record_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K241456",
   "fda_document_url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241456.pdf",
   "openfda_url": "https://api.fda.gov/device/510k.json?search=k_number:K241456",
   "short": "Celiac disease (HLA-DQ)",
   "topics": [
    "Celiac disease"
   ],
   "genes": [
    "HLA-DQ2.5",
    "HLA-DQ8",
    "HLA-DQ7",
    "HLA-DQ2.2"
   ],
   "reports": [
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241456.pdf",
     "quote": "The GlutenID Celiac GHR Test is indicated for reporting of one variant associated with the HLA-DQ2.5 haplotype, one variant associated with the HLA-DQ8 haplotype, one variant associated with the HLA-DQ7 haplotype, and three variants associated with the HLA-DQ2.2 haplotype."
    },
    {
     "src": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241456.pdf",
     "quote": "The report describes if a person has variants linked to haplotypes associated with an increased risk for developing celiac disease, but it does not describe a person’s overall risk of developing celiac disease."
    }
   ],
   "limits": [],
   "notes": []
  }
 ]
}