Cleared Traditional

BOND MMR Antibody Panel

K213348 · Leica Biosystems Newcastle, Ltd. · Pathology

Feb 2023

Decision

501d

Days

Class 2

Risk

About This 510(k) Submission

K213348 is an FDA 510(k) clearance for the BOND MMR Antibody Panel, a Lynch Syndrome Test System (Class II — Special Controls, product code PZJ), submitted by Leica Biosystems Newcastle, Ltd. (Newcastle Upon Tyne, GB). The FDA issued a Cleared decision on February 21, 2023, 501 days after receiving the submission on October 8, 2021. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1866.

Submission Details

510(k) Number	K213348 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 08, 2021
Decision Date	February 21, 2023
Days to Decision	501 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