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510(k) K213348

BOND MMR Antibody Panel by Leica Biosystems Newcastle, Ltd. — Product Code PZJ

K213348 is an FDA 510(k) premarket notification submitted by Leica Biosystems Newcastle, Ltd. for the device "BOND MMR Antibody Panel". The FDA issued a decision of Substantially Equivalent on February 21, 2023. The device falls under product code PZJ (Lynch Syndrome Test System), a Class II device regulated under 21 CFR 864.1866. Leica Biosystems Newcastle, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2023
Date Received
October 8, 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

Other clearances by Leica Biosystems Newcastle, Ltd.

  • K193393 — BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid (March 6, 2020)
  • K122556 — VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) (May 19, 2014)

Other clearances for product code PZJ

  • K211181 — Idylla MSI Test (February 27, 2023)
  • K200129 — OncoMate MSI Dx Analysis System (July 26, 2021)
  • DEN170030 — VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16 (October 27, 2017)

FDA data resources