VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)

K060227 · Vision Biosystems, Inc. · MYA · May 25, 2006 · Hematology

Device Facts

• Record ID: K060227
• Device Name: VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
• Applicant: Vision Biosystems, Inc.
• Product Code: MYA · Hematology
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.1860
• Device Class: Class 2

Intended Use

Vision Biosystems Estrogen Receptor Clone 6F11 is intended for laboratory use to qualitatively identify by light microscopy, estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded tissue. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells. Origin™ Mouse Monoclonal Antibody, Estrogen Receptor Clone 6F11 is intended for laboratory use to qualitatively identify by light microscopy, estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded tissue. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells. Origin™ antibodies are optimized for use with the Ventana® Medical Systems, NexES® and BenchMark™ Immunohistochemistry Staining Systems in combination with Ventana® Detection Kits.

Device Story

Vision BioSystems ER 6F11 is a monoclonal mouse antibody designed to detect estrogen receptor epitopes in the nuclei of ER-positive normal and neoplastic cells. The device is used in clinical laboratories by pathologists to process formalin-fixed, paraffin-embedded tissue samples. The antibody binds to the target antigen, allowing for visualization via light microscopy. The resulting staining pattern provides qualitative data that pathologists interpret alongside morphological studies, patient clinical history, and other diagnostic tests. This information assists in the management, prognosis, and prediction of therapy outcomes for breast cancer patients. The device is available in various formats, including lyophilized, liquid, and ready-to-use, and is compatible with specific automated immunohistochemistry staining systems.

Clinical Evidence

No clinical data provided. The submission relies on substantial equivalence to legally marketed predicate devices and compliance with FDA guidance for immunohistochemistry reagents.

Technological Characteristics

Mouse monoclonal antibody (clone 6F11); immunohistochemistry (IHC) principle; ready-to-use, concentrated, or lyophilized formats. Automated version uses phosphate buffer pH 7.3, 3 mg/ml carrier protein, 0.05% ProClin 300. Manual version uses 5% horse serum in PBS, 12mM sodium azide. Compatible with Ventana NexES/BenchMark automated staining systems. Standard IHC visualization via biotin-secondary/avidin-enzyme complex.

Indications for Use

Indicated for qualitative identification of estrogen receptor (ER) antigen in formalin-fixed, paraffin-embedded tissue sections via light microscopy. Used as an aid in management, prognosis, and therapy outcome prediction for breast cancer patients. Intended for professional laboratory use by qualified pathologists.

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.

Predicate Devices

• Ventana Medical Systems Estrogen Receptor Clone 6F11
• DAKO Corporation Mouse Monoclonal Estrogen Receptor Clone 1D5

Submission Summary (Full Text)

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K060227

MAY 2 5 2006

## 510(k) SUMMARY

:

| Date Prepared | January 27, 2006 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | |
| Submitter | Vision BioSystems, Inc.<br>700 Longwater Drive<br>Norwell, MA 02061 |
| Contact | Ron Lagerquist<br>Director, Regulatory Affairs |
| Device Name | Vision BioSystems Estrogen Receptor Clone 6F11<br>(ER 6F11) |
| Common/Usual/<br>Classification Name | Estrogen Receptor<br>Immunohistochemistry Reagents and Kits |
| Device Description | ER 6F11 is a monoclonal mouse antibody that<br>detects a human estrogen receptor epitope located<br>in the nucleus of ER positive cells. |
| Intended Use | ER 6F11 is intended for in vitro diagnostic use for the<br>qualitative detection of estrogen receptor in routinely<br>processed tissues. ER 6F11 is indicated as an aid in<br>the management, prognosis and prediction of<br>therapy outcome of breast cancer within the context<br>of the patient's clinical history and other diagnostic<br>tests evaluated by a qualified pathologist. |
| Substantial Equivalence | ER 6F11 is substantially equivalent to commercially<br>available immunohistochemistry ER antibodies such<br>as Ventana Medical Systems Estrogen Receptor<br>Clone 6F11, and DAKO Corporation Mouse<br>Monoclonal Estrogen Receptor Clone 1D5.<br>ER 6F11 complies with the elements of FDA<br>Guidance, "Guidance for Submission of<br>Immunohistochemistry Applications to the FDA" and,<br>"Guidance for Industry and FDA Staff - Use of<br>Symbols on Labels and in Labeling of In Vitro<br>Diagnostic Devices Intended for Professional Use. |

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and the control concerner

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized human figure embracing a globe, symbolizing the department's mission to protect and promote the health and well-being of Americans.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ronald F. Lagerquist, RAC Director, Regulatory Affairs Vision BioSystems, Inc. 700 Longwater Drive Norwell. MA 02061

MAY 2 5 2006

Re: k060227

Trade/Device Name: Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) Regulation Number: 21 CFR § 864.1860 Regulation Name: Immunohistochemistry Reagents and Kits Regulatory Class: II Product Code: MYA Dated: May 11, 2006 Received: May 12, 2006

Dear Mr. Lagerquist:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, 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 general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing 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 can be found in Title 21, Code of 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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.

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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/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PK. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number K06027

Device Name:

Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11)

- Lyophilized Mouse Monoclonal Antibody .
- Liquid Mouse Monoclonal Antibody .
- Ready to Use Mouse Monoclonal Antibody �
- Origin™ Mouse Monoclonal Antibody .

Indications for Use:

Vision BioSystems Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify by light microscopy, estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded tissue. Estrogen Receptor Clone 6F11 specifically binds to the ER antigen located in the nucleus of ER positive normal and neoplastic cells.

ER 6F11 is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Origin™ antibodies are optimized for use with the Ventana® Medical Systems. NexES® and BenchMark™ Immunohistochemistry Staining Systems in combination with Ventana® Detection Kits.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

KO 60227