Cleared Traditional

K192944 - AncestryDNA Factor V Leiden Genetic Health Risk Test

K192944 is an FDA 510(k) clearance for AncestryDNA Factor V Leiden Genetic Hea..., manufactured by Ancestry Genomics, Inc.. The device is a Class 2 Hematology device with product code PTA cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K192944 · Ancestry Genomics, Inc. · Hematology device
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Aug 2020
Decision
300d
Days
Class 2
Risk

K192944 is an FDA 510(k) clearance for the AncestryDNA Factor V Leiden Genetic Health Risk Test. Classified as Genetic Variant Detection And Health Risk Assessment System (product code PTA), Class II - Special Controls.

Submitted by Ancestry Genomics, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 13, 2020 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.5950 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ancestry Genomics, Inc. devices

FDA 510(k) Submission Details - K192944

510(k) Number K192944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2019
Decision Date August 13, 2020
Days to Decision 300 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 113d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PTA Device Classification - Class 2, Special Controls

Product Code PTA Genetic Variant Detection And Health Risk Assessment System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5950
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

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