Device class
Class II
Regulation 866.5950
Total clearances
4
2020-08-13 → 2025-01-07
Definition
What is Genetic Variant Detection And Health Risk Assessment System
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 persons overall risk of developing a disease.
Classification details
Medical specialty
Immunology
Regulation number
866.5950
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Helix Opco, LLC |
1 |
0 |
2020-12-23 |
|
Ancestry Genomics, Inc. |
1 |
0 |
2020-08-13 |
|
Progenika Biopharma S.A., A Grifols Company |
1 |
0 |
2022-10-27 |
|
Targeted Genomics, LLC |
1 |
0 |
2025-01-07 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 81479 |
CPT
|
— |
Medium
|
Unlisted molecular pathology procedure for genetic variant detection and health risk assessment |
| 81408 |
CPT
|
— |
Low
|
Genomic sequencing panel code if specific gene panel applicable |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-01-07 |
K241456 |
Targeted Genomics, LLC
|
GlutenID Celiac Genetic Health Risk Test |
| 2022-10-27 |
K221420 |
Progenika Biopharma S.A., A Grifols Company
|
AlphaID At Home Genetic Health Risk Service |
| 2020-12-23 |
K192073 |
Helix Opco, LLC
|
Helix Genetic Health Risk App for late-onset Alzheimers disease |
| 2020-08-13 |
K192944 |
Ancestry Genomics, Inc.
|
AncestryDNA Factor V Leiden Genetic Health Risk Test |