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Bond Oracle HER2 IHC System

by Leica Biosystems

PMA P090015

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P090015↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP090015 Date18 Apr 2012ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
SYSTEM, TEST, HER-2/NEU, IHC
PMA Number
FDA Product Code
MVC
Device Class
Class III
Advisory Committee
Pathology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Bond Oracle HER2 IHC System is a semi-quantitative immunohistochemical (IHC) assay designed to determine HER2 (human epidermal growth factor receptor 2) oncoprotein status. It is intended for use on formalin-fixed, paraffin-embedded breast cancer tissue samples prepared for histological evaluation.

This system is used in conjunction with the Bond-Max slide staining instrument to automate staining processes. Supplied as a diagnostic test, it aids in assessing patient eligibility for HERCEPTIN (trastizumab) treatment by providing HER2 status results. The device is approved under an FDA Premarket Approval (PMA) and classified as a Class III medical device.