23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia

DEN160026

23andMe, Inc. · granted 2017-04-06 · product code PTA · Immunology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The 23andMe PGS is a currently-marketed, non-invasive genetic information service that combines qualitative genotyping data covering genetic ancestry, traits, and certain heritable health conditions from a single multiplex assay with descriptive information derived from peer reviewed, published genetic research studies. It is a direct-to-consumer, over-the-counter, non-diagnostic, DNA genetic testing service intended to provide information and tools for individual users.”
AlgorithmSoftware packages (GenomeStudio and Coregen) are used to view, analyze genotypic data, conduct control checks, and determine genotype profiles for each sample.
source quote (p.5)
“GenomeStudio is a modular software application that is used to view and analyze genotypic data obtained from the iScan. Coregen software conducts a variety of control checks on the file, resulting in a final genotype profile for each sample. These data are used to generate test reports on a user's genotype and associated risk of disease.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Standalone

n=80 cases · 1 site(s)

endpoints: genotype assignment agreement with Sanger bidirectional sequencing; percent agreement (PA)

Bench

n=5 other · 2 site(s)

endpoints: imprecision due to assay run, lot, instrument, operator, day, and site

Standalone

n=764 patients · 6 site(s)

endpoints: assess user comprehension of representative labeling contained in the Genetic Health Risk reports; comprehension accuracy rates for multiple core comprehension concepts

Reported performance (2 observations)

agreement_kappaas written: “Percent Agreement (PA) for various genotypes across multiple variants”stated without value
source quote (p.23)
“Percent Agreement (PA) of PGS test results with comparator results of saliva samples: PA (CC|CC) = 100% (68/68) with 95% CI: 94.7% to 100%; PA (CT|CT) = 100% (68/68) with 95% CI: 94.7% to 100%; PA (TT|TT) =100% (67/67) with 95% CI: 94.6% to 100%; Percent of no calls or invalid is 0.0% (0/203) with 95% CI: 0.0% to 1.9%.”
ppvas written: “Technical (analytical) positive predictive values for various genotypes across multiple variants”stated without value
source quote (p.23)
“The minor variant frequency for Factor V Leiden in individuals of European descent reported in published literature is 3%-15%; technical (analytical) positive predictive values for 23andMe PGS test results of CT and TT are ≥ 99.5% and ≥ 99.1% correspondingly.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Immunology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN160026