FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K935161

Device Name

KERATIN PRIMARY ANTIBODY

Manufacturer

VENTANA MEDICAL SYSTEMS, INC.

Date Cleared

1996-03-22

(875 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Ventana Medical Systems, Inc. developed the Ventana Keratin Primary Antibody for use on the Ventana 320 automated immunohistochemistry system.

Device Description

Ventana Keratin Primary Antibody for use on the Ventana 320 automated immunohistochemistry system.

AI/ML Overview

Here's an analysis of the provided text regarding the Ventana Keratin Primary Antibody, structured according to your request:

Device: Ventana Keratin Primary Antibody (clone 5D3) for use on the Ventana 320 automated immunohistochemistry system.

Description of Acceptance Criteria and Study:

The primary acceptance criteria for the Ventana Keratin Primary Antibody (clone 5D3) is its substantial equivalence to a commercially available anti-human cytokeratin (clone CAM 5.2). This equivalence is demonstrated through a comparative study evaluating staining patterns, intensity, specificity, and sensitivity in various tissue samples.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Metric	Acceptance Threshold (Implied)	Reported Device Performance
Equivalence to Comparator	Staining in Epithelial Cancers	~100% agreement with comparator	91% agreement with comparator in epithelial line cancers
Specificity (Non-Epithelial Cancers)	No staining in non-epithelial cancers	0% staining	Neither antibody stained any non-epithelial type cancers
Normal Tissue Staining	Appropriate staining patterns	Qualitative assessment of appropriateness	Staining patterns of normal tissues considered appropriate
Staining Intensity	No statistically significant difference from comparator	p