Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AncestryDNA Factor V Leiden Genetic Health Risk Test

K-Number: K192944 · 2020-08-13

ApplicantAncestry Genomics, Inc.
Decision Date2020-08-13
Product CodePTA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AncestryDNA Factor V Leiden Genetic Health Risk Test is a medical device manufactured by Ancestry Genomics, Inc.. It received FDA 510(k) clearance on 2020-08-13 under approval number K192944. The device is classified under product code PTA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AncestryDNA Factor V Leiden Genetic Health Risk Test?

AncestryDNA Factor V Leiden Genetic Health Risk Test is a medical device that received FDA 510(k) clearance on 2020-08-13. It is manufactured by Ancestry Genomics, Inc.. The 510(k) number is K192944.

When was AncestryDNA Factor V Leiden Genetic Health Risk Test approved by the FDA?

AncestryDNA Factor V Leiden Genetic Health Risk Test received FDA 510(k) clearance on 2020-08-13, under approval number K192944.

What company makes AncestryDNA Factor V Leiden Genetic Health Risk Test?

AncestryDNA Factor V Leiden Genetic Health Risk Test is manufactured by Ancestry Genomics, Inc..

What is the FDA product code for AncestryDNA Factor V Leiden Genetic Health Risk Test?

The FDA product code for AncestryDNA Factor V Leiden Genetic Health Risk Test is PTA.

Related Clinical Trials

NCT03590327 Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment COMPLETED NCT07366424 Evaluating the Impact of "CHUT OTONOM®" Footwear on the Spatio-temporal Parameters of Walking and the Risk of Falls in Elderly People at High Risk of Falling. RECRUITING NCT06507748 A Study to Evaluate the Feasibility of a Physiologic Biomarker to Assess Pain and Other Sensory Problems Using Pupillometry in Participants With Neurofibromatosis Type 1 (NF1) RECRUITING NCT07288463 Hearing Loss and Brain Health Study NOT_YET_RECRUITING NCT06808880 EXpanding Prenatal Cell Free DNA Screening Across moNogenic Disorders (EXPAND) RECRUITING NCT07561957 A Smart Phone Application to Improve Adoption of the 2024 Kidney Disease Improving Global Outcomes (KDIGO) Chronic Kidney Disease (CKD) Guidelines RECRUITING

Related PubMed Literature

PMID: 41915995 Inflammation-metabolism-fibrosis axis: mechanisms and therapeutic strategies targeting the chronicity of pelvic inflammatory disease. International immunopharmacology (2026) PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026) PMID: 39900769 Regulatory Perspectives for Gene Expression-Based Diagnostic Devices. Methods in molecular biology (Clifton, N.J.) (2025)

Other Devices by Ancestry Genomics, Inc.

K192947AncestryDNA Saliva Collection Kit

Related Devices (Code: PTA)

DEN16002623andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia23AndMe, Inc. K192073Helix Genetic Health Risk App for late-onset Alzheimer’s diseaseHelix Opco, LLC K221420AlphaID™ At Home Genetic Health Risk ServiceProgenika Biopharma S.A., A Grifols Company K241456GlutenID Celiac Genetic Health Risk TestTargeted Genomics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑