MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI

K120663 · Dako North America, Inc. · MYA · Feb 12, 2013 · Hematology

Device Facts

• Record ID: K120663
• Device Name: MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI
• Applicant: Dako North America, Inc.
• Product Code: MYA · Hematology
• Decision Date: Feb 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1860
• Device Class: Class 2

Intended Use

For in vitro diagnostic use. FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use, (LINK), is intended for use in immunohistochemistry with EnVision™ FLEX, High pH visualization kit together with Autostainer Link 48 to semi-quantitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas. 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.

Device Story

Device is a ready-to-use monoclonal rabbit antibody (Clone EP1) for immunohistochemical (IHC) staining of human breast cancer tissue. Used with Dako Autostainer Link 48 and EnVision FLEX High pH visualization kit. Input: formalin-fixed, paraffin-embedded tissue sections. Process: antibody binds to estrogen receptor alpha proteins in cell nuclei; visualization kit enables detection. Output: stained tissue slides for microscopic examination by a qualified pathologist. Context: clinical laboratory setting; operated by trained laboratory personnel. Pathologist interprets staining patterns in conjunction with clinical history and other diagnostic tests to assess estrogen receptor status, aiding in breast carcinoma prognosis.

Clinical Evidence

Bench testing only. Performance characteristics evaluated include specificity, sensitivity, reproducibility, and concordance testing compared to the predicate device. Results demonstrated substantial equivalence.

Technological Characteristics

Ready-to-use monoclonal rabbit antibody (Clone EP1) in liquid buffer with stabilizing protein and 0.015 mol/L sodium azide. Working concentration ~3.7 ug/mL; total protein ~10 mg/mL. Optimized for use with Dako Autostainer Link 48 automated staining system. Principle: immunohistochemistry (IHC) for semi-quantitative protein detection.

Indications for Use

Indicated for in vitro diagnostic use to semi-quantitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer to assess estrogen receptor status.

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

• ER a component of the Dako ER/PR pharmDx™ Kit (K042884)

Submission Summary (Full Text)

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K120663

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510(k) Pre-Market Notification for Dako Anti-Human ER α Clone EP1

FEB 1 2 2013

# 7. 510(K) Summary

# 7.1.1 Assigned 510(k) Number

The assigned 510(k) number is K120663

### 7.2 Sponsor Name and Address

Dako North America, Inc 6392 Via Real Carpinteria, CA 93013 Phone: [phone] Fax: [phone]

Establishment registration No: 2022180

### 7.3 Contact

Xiaolei Xu, Ph.D. Requlatory Affairs Manager E-mail: [e-mail] Phone direct: 1 805 566 3013 Fax: [phone]

### Summary Prepared February 28, 2012 7.4

- Summary Revised Feb 4, 2013 7.5
### 7.6 Device Name(s)

Trade name(s)

Dako Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1, FLEX, Ready- to-Use (RTU) Link Product code: IR084

Common name(s) Classification:

Dako Anti-Human ER a, Clone EP1 Class II (21 CFR 864.1860)

Dako North America, Inc

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510(k) Pre-Market Notification for Dako Anti-Human ER a Clone EP1

#### 7.7 Predicate Device:

ER a component of the Dako ER/PR pharmDx™ Kit (K042884)

### 7.8 Device Description

Dako Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 (Dako Anti-Human ER a, clone EP1) antibody is utilized to perform a semi-quantitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The ER a antibody is available in Ready-to-Use (RTU) format and is optimized for use with Dako Automated stainer Link 48. The RTU Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 is provided in one vial of ready-to-use monoclonal rabbit antibody contains 12 ml of reagent provided in liguid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The working Ig concentration of the antibody is approximately 3.7 ug/mL. Total protein concentration is approximately 10mg/mL.

### 7.9 Intended Use:

### For in vitro diagnostic use.

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use, (LINK), is intended for use in immunohistochemistry with EnVision™ FLEX, High pH visualization kit together with Autostainer Link 48 to semi-quantitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.

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.

### 7.10 Substantial Equivalence

Dako Anti-Human ER q. clone EP1 Antibody IHC assay is substantially equivalent to the ER a component of the Dako ER/PR pharmDx™ Kit. Both products specifically bind to estrogen receptor proteins located in the nuclei of cells, these products require similar detection chemistry principles for visualization of the product, and both aid in

Dako North America, Inc

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510(k) Pre-Market Notification for Dako Anti-Human ER α Clone EP1

the prognosis of breast carcinoma. The difference in visualization between the predicate device and Anti-human ER a Antibody, Clone EP1 does not introduce new issues of safety and effectiveness.

## 7.11 Performance Characteristics:

Performance characteristics evaluated in support of the Dako Anti-Human ER o, clone EP1 IHC assay include results on specificity, sensitivity, reproducibility, and concordance testing. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate device listed above.

Therefore, based on the information provided in this premarket notification, Dako concludes that the device listed above is safe, effective and substantially equivalent to the predicate device in the indication for use, device design, materials, operational principles, and intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

# February 12, 2013

Dako North America, Inc c/o Dr. Xiaolei Xu Regulatory Affairs Manager 6392 Via Real Carpinteria, California 93013

Re: k120663

Trade/Device Name: FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link)

Regulation Number: 21 CFR §864.1860

Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: II Product Code: MYA Dated: January 16, 2013 Received: January 24, 2013

Dear Dr. Xu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Dr. Xiaolei Xu

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Reena Philip -S

for

Maria M. Chan, Ph.D.

Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# 510(k) Number (if known): K120663

Device Name:

Monoclonal Rabbit Anti- Human Estrogen Receptor a, Clone EP1 FLEX Ready-to-Use (Link) Product Code IR084

Indications For Use:

For in vitro diagnostic use.

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Readyto-Use, (LINK), is intended for use in immunohistochemistry with EnVision™ FLEX, High pH visualization kit together with Autostainer Link 48 to semiquantitatively detect human estrogen receptor in formalin-fixed, paraffinembedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donne Rowe

**Division Sign-Off**

Citico of in Vitro Diagnostics and Radiological Health

5068KI K/20663

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