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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device genetic variant detection and health risk assessment system
Regulation Description Genetic health risk assessment system.
Definition A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users of lifestyle choices and/or encourage conversations with a healthcare professional. This assessment system is for over-the-counter use. This device does not determine the person’s overall risk of developing a disease.
Product CodePTA
Regulation Number 866.5950
Device Class 2


Premarket Reviews
ManufacturerDecision
PROGENIKA BIOPHARMA S.A., A GRIFOLS COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TARGETED GENOMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 1 1
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1
Insufficient Information 1 1

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