Device class
Class II
Regulation 864.1866
Total clearances
3
2021-07-26 → 2023-02-27
Definition
What is Lynch Syndrome Test System
The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome
Classification details
Medical specialty
Immunology
Regulation number
864.1866
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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 |
| 81295 |
CPT
|
— |
High
|
CPT for microsatellite instability (MSI) testing in tumor tissue |
| 81297 |
CPT
|
— |
High
|
CPT for mismatch repair gene panel testing (MLH1, MSH2, MSH6, PMS2) |
Pulse
Most recent 510(k) clearances