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510(k) K192944

AncestryDNA Factor V Leiden Genetic Health Risk Test by Ancestry Genomics, Inc. — Product Code PTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2020
Date Received
October 18, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Genetic Variant Detection And Health Risk Assessment System
Device Class
Class II
Regulation Number
866.5950
Review Panel
IM
Submission Type

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.

Other clearances by Ancestry Genomics, Inc.

  • K192947 — AncestryDNA Saliva Collection Kit (August 13, 2020)

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