510(k) K211181

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

February 27, 2023

Date Received

April 20, 2021

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Lynch Syndrome Test System

Device Class

Class II

Regulation Number

864.1866

Review Panel

PA

Submission Type

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