ARIOL HER-2/NEU IHC

K031715 · Applied Imaging Corp. · NOT · Jan 8, 2004 · Hematology

Device Facts

• Record ID: K031715
• Device Name: ARIOL HER-2/NEU IHC
• Applicant: Applied Imaging Corp.
• Product Code: NOT · Hematology
• Decision Date: Jan 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1860
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

The Applied Imaging Ariol™ is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This Hersight application is intended for use as an accessory to the HercepTest™ (DAKO USA, Carpinteria, CA) and is intended to provide semi-quantitative immunohistochemical (IHC) results to aid in the determination of HER-2/neu (HER2) over-expression in breast cancer tissues routinely processed for histological evaluation. When used with DAKO HercepTest, it is indicated for use as an aid in the assessment of breast cancer patients for whom Herceptin® (Trastuzumab) treatment is being considered. Note: The actual correlation of the DAKO HercepTest to Herceptin clinical outcome has not been cstablished. The Ariol system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the DakoCytomation HercepTest to assure the validity of the Ariol-assisted HER2 score.

Device Story

Ariol™ is an automated scanning microscope and image analysis system. It captures digital images of histological breast cancer slides stained with DAKO HercepTest. The system performs automated detection, classification, and counting of cells based on color, intensity, size, pattern, and shape. It provides semi-quantitative IHC results to assist pathologists in determining HER2 over-expression. Used in clinical laboratory settings by pathologists to improve reproducibility of HER2 scoring. The output serves as an adjunctive tool; the pathologist remains responsible for final interpretation and validation using morphological studies and controls. The system benefits patients by providing standardized, computer-assisted measurements to support treatment decisions regarding Herceptin therapy.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Automated scanning microscope with motorized stage, focus, and filter wheels. Uses colorimetric pattern recognition for image analysis. Calibration requires laboratory-stained 1+ and 3+ training slides per staining run. Software-based classification of membrane and nuclei. Standalone workstation including computer, monitor, and printer. Bar-code sample identification.

Indications for Use

Indicated for use as an aid to pathologists in the detection, classification, and counting of cells in breast cancer tissue specimens stained for HER2 receptor protein to assess patients being considered for Herceptin (Trastuzumab) treatment.

Regulatory Classification

Identification

Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.

Special Controls

(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

JAN - 8 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Diane C. Oates Applied Imaging Corp. 2380 Walsh Avenue - Bldg. B Santa Clara, GA 95051

> k031715 Trade/Device Name: Ariol™ HER-2/neu IHC Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: Class II Product Code: NOT Dated: October 24, 2003 Received: October 27, 2003

Dear Ms. Oates:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the entribute) is the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefere, mains of the Act include requirements for annual registration, listing of general controll proficturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device n may or subject to back and Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease be actives and i 1975 that I DT has Intact and regulations administered by other Federal agencies. You must or any I citizates as a s requirements, including, but not limited to: registration and listing (21 Comply with and 1100 (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INTENDED USE

510(K) Number (if known): ____K031715

Device Name: Ariol™ HER-2/neu IHC

## Indications for Use:

The Applied Imaging Ariol™ is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape.

This Hersight application is intended for use as an accessory to the HercepTest™ (DAKO USA, Carpinteria, CA) and is intended to provide semi-quantitative immunohistochemical (IHC) results to aid in the determination of HER-2/neu (HER2) over-expression in breast cancer tissues routinely processed for histological evaluation.

When used with DAKO HercepTest, it is indicated for use as an aid in the assessment of breast cancer patients for whom Herceptin® (Trastuzumab) treatment is being considered. Note: The actual correlation of the DAKO HercepTest to Herceptin clinical outcome has not been cstablished.

The Ariol system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the DakoCytomation HercepTest to assure the validity of the Ariol-assisted HER2 score.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:flex; align-items:center;"> <div style="margin-right:5px;">✓</div> <div>OR</div> </div> | Over--the-Counter Use ______ |
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| | marie m chan |
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Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | K031715 |
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