Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device genetic variant detection and 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
23ANDME, INC.
  GRANTED 1
ANCESTRY GENOMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HELIX OPCO, LLC
  SUBSTANTIALLY EQUIVALENT 1
PROGENIKA BIOPHARMA S.A., A GRIFOLS COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Test Result 1 1

-
-