Cleared Traditional

K211181 - Idylla MSI Test
(FDA 510(k) Clearance)

K211181 · Biocartis NV · Pathology

Feb 2023

Decision

678d

Days

Class 2

Risk

K211181 is an FDA 510(k) clearance for the Idylla MSI Test, a Lynch Syndrome Test System (Class II — Special Controls, product code PZJ), submitted by Biocartis NV (Mechelen, BE). The FDA issued a Cleared decision on February 27, 2023, 678 days after receiving the submission on April 20, 2021. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1866.

Submission Details

510(k) Number	K211181 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 2021
Decision Date	February 27, 2023
Days to Decision	678 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	PZJ — Lynch Syndrome Test System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.1866
Definition	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