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Ventana Image Analysis System - Pathway HER2 (4B5)

by Tripath Imaging

510(k) K061613

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061613 Date10 Jan 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0571-2008 FDA Unclassified (pre-2012) initiated 26 Jun 2007

    Incomplete upgrade: The software upgrade from February 1, 2007 may not have been completed. This software upgrade adds the algorithm (Slidetype) for the PATHWAY anti-HER-2/neu (4B5) antibody to the VIAS system.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NQN
Device Class
Class II
Regulation
21 CFR Part 864.1860
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Ventana Image Analysis System - Pathway Her2 (4B5) is an automated, operator-intervention microscope designed for immunohistochemistry (IHC) image analysis. It quantifies nuclear intensity and percent positivity of HER2/neu expression in tissue samples using digital imaging and specialized software. This system supports diagnostic assessment in hematology, particularly for evaluating HER2 status in breast cancer pathology. As a Class II medical device, it integrates microscopy, digital capture, and algorithmic analysis to assist pathologists in standardized HER2 scoring.

This system is supplied as a standalone device for laboratory use, requiring operator intervention to select and analyze slides stained with the VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody. It operates in non-sterile settings and is intended for single-use per slide analysis, though the hardware itself may be reusable across multiple procedures. The device complies with FDA 510(k) clearance (K061613) under the Hematology advisory committee, with no specific MRI safety restrictions noted. Storage and handling follow standard laboratory protocols for automated IHC analysis equipment.

Other devices from Tripath Imaging, Inc.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Ventana Image Analysis System - Pathway HER2 (4B5) used for?

    This system is designed for immunohistochemistry (IHC) image analysis to quantify nuclear intensity and percent positivity of HER2/neu expression in tissue samples. It assists pathologists in evaluating HER2 status, particularly in breast cancer diagnostics, by providing standardized scoring through automated digital imaging and specialized software.

  • How is the Ventana Image Analysis System - Pathway HER2 (4B5) supplied and intended for use?

    The device is supplied as a standalone unit for laboratory use and requires operator intervention to select and analyze slides. It is intended for single-use per slide analysis when paired with the VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody. The hardware itself is reusable across multiple procedures, but each slide analysis is considered a single-use event.

  • Is the Ventana Image Analysis System - Pathway HER2 (4B5) sterile, and where should it be used?

    The system is not sterile and is designed for use in non-sterile laboratory settings. It adheres to standard laboratory protocols for automated immunohistochemistry (IHC) analysis equipment, ensuring proper handling and maintenance in a controlled diagnostic environment.

  • Can the Ventana Image Analysis System - Pathway HER2 (4B5) be reused for multiple procedures?

    The hardware of the Ventana Image Analysis System is reusable across multiple procedures, but each slide analysis is intended for single-use. This means the device itself can be used repeatedly, but the analysis of individual slides follows a single-use protocol to maintain accuracy and reliability.

  • What regulatory clearance does the Ventana Image Analysis System - Pathway HER2 (4B5) hold?

    The device holds FDA 510(k) clearance (K061613) under the Hematology advisory committee, classified as substantially equivalent to existing devices. This clearance was granted in 2007, confirming its compliance with regulatory standards for automated microscopy and image analysis in hematology diagnostics.