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)

AlphaID™ At Home Genetic Health Risk Service

K-Number: K221420 · 2022-10-27

ApplicantProgenika Biopharma S.A., A Grifols Company
Decision Date2022-10-27
Product CodePTA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AlphaID™ At Home Genetic Health Risk Service is a medical device manufactured by Progenika Biopharma S.A., A Grifols Company. It received FDA 510(k) clearance on 2022-10-27 under approval number K221420. 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 AlphaID™ At Home Genetic Health Risk Service?

AlphaID™ At Home Genetic Health Risk Service is a medical device that received FDA 510(k) clearance on 2022-10-27. It is manufactured by Progenika Biopharma S.A., A Grifols Company. The 510(k) number is K221420.

When was AlphaID™ At Home Genetic Health Risk Service approved by the FDA?

AlphaID™ At Home Genetic Health Risk Service received FDA 510(k) clearance on 2022-10-27, under approval number K221420.

What company makes AlphaID™ At Home Genetic Health Risk Service?

AlphaID™ At Home Genetic Health Risk Service is manufactured by Progenika Biopharma S.A., A Grifols Company.

What is the FDA product code for AlphaID™ At Home Genetic Health Risk Service?

The FDA product code for AlphaID™ At Home Genetic Health Risk Service is PTA.

Related Clinical Trials

NCT03590327 Transcranial Magnetic Stimulation for Apathy in Mild Cognitive Impairment COMPLETED NCT07598305 PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers COMPLETED 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 NCT07581301 Administering Atropine Through Autoinjectors Within Ambulance Services for Poisoning Patients in Sri Lanka's North Central Province NOT_YET_RECRUITING NCT07049419 The Impact of Environmental Controls on Mental Health COMPLETED NCT06808880 EXpanding Prenatal Cell Free DNA Screening Across moNogenic Disorders (EXPAND) RECRUITING

Related PubMed Literature

PMID: 39900769 Regulatory Perspectives for Gene Expression-Based Diagnostic Devices. Methods in molecular biology (Clifton, N.J.) (2025) PMID: 32342752 Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2020) PMID: 27449572 "The Google of Healthcare": enabling the privatization of genetic bio/databanking. Annals of epidemiology (2016) PMID: 25705152 Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing. Genomics & informatics (2014)

Other Devices by Progenika Biopharma S.A., A Grifols Company

K171868A1AT Genotyping Test K192858A1AT Genotyping Test K211115A1AT Genotyping Test

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 K192944AncestryDNA Factor V Leiden Genetic Health Risk TestAncestry Genomics, Inc. 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.

↑