Cleared Traditional

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

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211181 · Biocartis NV · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
678d
Days
Class 2
Risk

K211181 is an FDA 510(k) clearance for the Idylla MSI Test. Classified as Lynch Syndrome Test System (product code PZJ), Class II - Special Controls.

Submitted by Biocartis NV (Mechelen, BE). The FDA issued a Cleared decision on February 27, 2023 after a review of 678 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1866 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

View all Biocartis NV devices

Submission Details

510(k) Number K211181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
601d slower than avg
Panel avg: 77d · This submission: 678d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZJ Lynch Syndrome Test System
Device Class Class 2 - 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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.