Device class
Class II
Regulation 866.6080
Total clearances
6
2020-04-24 → 2026-05-12
Definition
What is Next Generation Sequencing Based Tumor Profiling Test
A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing.
Classification details
Medical specialty
Pathology
Regulation number
866.6080
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Personal Genome Diagnostics
|
1 |
0 |
2020-04-24 |
|
Act Genomics |
1 |
0 |
2022-12-23 |
|
Nyu Langone Medical Center |
1 |
0 |
2021-07-14 |
|
Geneseeq Technology, Inc. |
1 |
1 |
2025-08-29 |
|
Datar Cancer Genetics Private Limited |
1 |
1 |
2026-05-12 |
|
Tempus AI, Inc.
|
1 |
1 |
2025-09-19 |
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 |
| 81455 |
CPT
|
— |
High
|
CPT for targeted mutation analysis, single gene or gene family by next-generation sequencing |
| 81457 |
CPT
|
— |
Medium
|
CPT for multigene analysis by NGS (when panel includes multiple genes) |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-05-12 |
K260235 |
Datar Cancer Genetics Private Limited
|
CellDx-Tissue |
| 2025-09-19 |
K241868 |
Tempus AI, Inc.
|
xR IVD |
| 2025-08-29 |
K250003 |
Geneseeq Technology, Inc.
|
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) |
| 2022-12-23 |
K210017 |
Act Genomics
|
ACTOnco, ACTOnco IVD |
| 2021-07-14 |
K202304 |
Nyu Langone Medical Center
|
NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) |
| 2020-04-24 |
K192063 |
Personal Genome Diagnostics
|
PGDx elio tissue complete |