MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)

K130861 · Dako North America, Inc. · MXZ · Dec 9, 2013 · Hematology

Device Facts

• Record ID: K130861
• Device Name: MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
• Applicant: Dako North America, Inc.
• Product Code: MXZ · Hematology
• Decision Date: Dec 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.1860
• Device Class: Class 2

Intended Use

For in vitro diagnostic use Flex Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (LINK) is intended for use in immunohistochemistry with EnVision™ FLEX +, High pH visualization kit together with the Autostainer Link 48 instrument to semi quantitatively detect human progesterone receptor in formalin fixed, paraffin embedded human breast carcinoma. This antibody labels progesterone receptor positive cells and is useful in the assessment of progesterone 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 an immunohistochemistry (IHC) reagent kit using monoclonal mouse anti-human progesterone receptor (clone PgR 636). Input is FFPE breast carcinoma tissue sections. Process involves heat-induced epitope retrieval (HIER), incubation with primary antibody, and application of EnVision™ FLEX+ visualization system (HRP-linked) on the Autostainer Link 48 instrument. Enzymatic conversion of DAB+ chromogen creates visible reaction product at antigen sites. Output is stained slide for light microscopy. Used in clinical pathology labs; operated by trained laboratory personnel. Pathologists interpret staining (positive if ≥1% tumor nuclei stained) to determine PR status, informing breast cancer treatment decisions. Benefits include standardized, automated PR assessment.

Clinical Evidence

Clinical performance evaluated via concordance and reproducibility studies. Concordance study (n=236) compared PgR 636 to predicate, showing 94.5% overall agreement, 95.8% positive agreement, and 93.1% negative agreement. Reproducibility study involved 21 unique breast cancer specimens evaluated across three laboratories over five days (315 total evaluations), demonstrating high inter-laboratory and inter-instrument reproducibility.

Technological Characteristics

Monoclonal mouse anti-human antibody (Clone PgR 636) in liquid buffer with stabilizing protein and 0.015 mol/L sodium azide. Target concentration 0.5 ug/mL (range 0.4-0.6 ug/mL). Optimized for automated IHC staining on Dako Autostainer Link 48. Uses EnVision™ FLEX+, High pH visualization chemistry. Detects nuclear PR protein expression.

Indications for Use

Indicated for semi-quantitative detection of human progesterone receptor (PR) in formalin-fixed, paraffin-embedded (FFPE) human breast carcinoma tissue to assist in assessing PR 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

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

Submission Summary (Full Text)

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An Agilant Technolog

510(k) for Anti-PR, Clone PgR 636

K130861 DEC - 9 2013

### 510(k) Summary 5.

Traditional Premarket Notification Submission (510(k)) Summary Prepared in accordance with 21 CFR 807.92

### 5.1 Submitter Information

| Sponsor name: | Dako North America, Inc. |
|-----------------------------|--------------------------------------------|
| Sponsor address: | 6392 Via Real<br>Carpinteria, CA 93013 USA |
| Sponsor Telephone: | 805-566-6655 |
| Sponsor Fax: | 805-566-6688 |
| Establishment Registration: | 2022180 |

C

| Contact person: | Jennifer Michelle Chambers<br>MPA, MBA, CQA (ASQ) |
|---------------------------|---------------------------------------------------------|
| Contact title: | Regulatory Affairs Specialist, Dako North America, Inc. |
| Email Direct (preferred): | [e-mail] |
| Telephone Direct: | 805-566-3036 |
| Date Summary Prepared: | March 22, 2013 |

### 5.2 Device Name

| Trade (proprietary): | FLEX Monoclonal Mouse Anti-Human Progesterone<br>Receptor, Clone PgR 636, Ready-to-Use, (Link) |
|----------------------|------------------------------------------------------------------------------------------------|
| Common (usual): | Anti-PR, Clone PgR 636 |
| Classification: | 21 CFR 864.1860: Immunohistochemistry (IHC)<br>Reagents and Kits (Class II) |
| FDA Device Code: | MXZ: Immunohistochemistry Assay, Antibody.<br>Progesterone Receptor |
| Panel: | 88 (Pathology) |

### 5.3 Substantially Equivalent Predicate Device

| Device Name: | PR component of the Dako ER/PR pharmDx™ Kit |
|----------------|---------------------------------------------|
| Device 510(k): | K042884 |

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Image /page/1/Picture/1 description: The image shows the logo for Dako, an Agilent Technologies company. The logo consists of a stylized flame-like symbol on the left, followed by the word "Dako" in bold, sans-serif font. Below "Dako" is the text "An Agilent Technologies Company" in a smaller, sans-serif font. The logo is black and white.

Table 3. Agreement between Anti-PR, Clone PgR 636 (ASCO/CAP) and Anti-PR Component of ER/PR pharmDx™ Kit (ASCO/CAP)

| Anti-PR Component of ER/PR pharmDx™ Kit | | | | |
|-----------------------------------------|----------|----------|----------|-------|
| | | Positive | Negative | Total |
| Anti-PR,<br>Clone PgR | Positive | 115 | 8 | 123 |
| 636 | Negative | 1 | 112 | 113 |
| | Total | 116 | 120 | 236 |

Positive Percent Agreement = 99.1% (95% CI: 93.0-98.0) Negative Percent Agreement = 93.3% (95% CI: 92.8-98.0) Overall Percent Agreement = 96.2% (95% Cl: 93.0-98.0)

Table 4. Site 1 vs. Site 2 Inter Laboratory Reproducibility of Anti-PR, Clone PgR 636

| | Site 1 | | | |
|--------|----------|----------|----------|-------|
| | | Positive | Negative | Total |
| Site 2 | Positive | 55 | 0 | 55 |
| | Negative | 4 | 46 | 50 |
| | Total | 59 | 46 | 105 |

Average Positive Percent Agreement = 96.5% Average Negative Percent Agreement = 95.8%

| Table 5. Site 1 vs. Site 3 Inter Laboratory Reproducibility of Anti-PR, Clone PgR 636 | | | | | |
|---------------------------------------------------------------------------------------|--|--|--|--|--|
|---------------------------------------------------------------------------------------|--|--|--|--|--|

| | | Site 1 | | | |
|--------|----------|----------|----------|-------|--|
| | | Positive | Negative | Total | |
| Site 3 | Positive | 59 | 1 | 60 | |
| | Negative | 0 | 45 | 45 | |
| | Total | 59 | 46 | 105 | |

Average Positive Percent Agreement = 99.2% Average Negative Percent Agreement = 98.9%

Table 6. Site 2 vs. Site 3 Inter Laboratory Reproducibility of Anti-PR, Clone PgR 636

| | Site 2 | | | |
|--------|----------|----------|----------|-------|
| Site 3 | | Positive | Negative | Total |
| | Positive | 55 | 5 | 60 |
| | Negative | 0 | 45 | 45 |
| | Total | 55 | 50 | 105 |

Average Positive Percent Agreement = 95.7% Average Negative Percent Agreement = 94.7%

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Image /page/2/Picture/0 description: The image shows the logo for Dako, an Agilent Technologies company. The logo consists of a stylized symbol resembling a drop or flame, followed by the word "Dako" in a bold, sans-serif font. Below "Dako" is the text "An Agilent Technologies Company" in a smaller, also sans-serif font. The logo is black and white.

### Device Description 5.4

Dako FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link) antibody is utilized to semi-quantitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded (FFPE) human breast carcinoma. This product is pre-diluted and optimized for use with the Dako Autostainer Link 48 automated slide staining platform. Anti-PR, Clone PgR 636 is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The target concentration of Anti-PR, Clone PgR 636 is 0.5 ug/mL; the acceptable concentration range is 0.4 ug/mL to 0.6 ug/mL.

#### 5.5 Intended Use

For in vitro diagnostic use.

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-touse (Link) is intended for use in immunohistochemistry with EnVision™ FLEX+, High pH visualization kit together with Autostainer Link 48 instrument to semi-quantitatively detect human progesterone receptor in formalin-fixed, paraffin-embedded (FFPE) human breast carcinoma. This antibody labels progesterone receptor-positive cells and is useful in the assessment of progesterone 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.

### Technological Characteristics 5.6

Dako FLEX Monoclonal Mouse Anti-Human Progesterone Receptor. Clone PoR 636. Ready-to-use (Link) Antibody IHC assav and the predicate PR component of the Dako ER/PR pharmDx™ Kit both specifically bind to PR proteins located in the cell nucleus of PR-expressing cells, and are optimized for use on formalin-fixed, paraffin-embedded (FFPE) tissues. Both products aid in the prognosis of breast carcinoma, both products have equivalent staining performance, and both products require similar detection chemistry principles for visualization of the product. The difference in visualization between the predicate device and Anti-PR, Clone PgR 636 has been clinically validated to ensure it does not introduce new issues of safety or effectiveness.

### Performance Characteristics (Nonclinical) 5.7

Nonclinical Performance characteristics evaluated in support of the FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-use (Link) Antibody IHC assay include analytical specificity and precision. Study results demonstrate a substantial degree of equivalency to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for Dako, an Agilent Technologies company. The logo consists of a stylized symbol resembling a drop or flame, followed by the word "Dako" in bold, sans-serif font. Below "Dako" is the text "An Agilent Technologies Company" in a smaller font size.

### 5.8 Performance Characteristics (Clinical)

Clinical Performance characteristics evaluated in support of the FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-use (Link) Antibody IHC assay include concordance and reproducibility. Summaries of all performance testing are provided in the Executive Summary of this 510(k). Full reports of all performance testing are provided in the Performance Testing (Clinical) section of this 510(k).

Concordance: Anti-PR, Clone PgR 636 testing was performed with EnVision™ FLEX+ and scored according to ASCO/CAP quidelines (≥1% cut-off) (11). Anti-PR (Clone 1294) testing was performed using Dako ER/PR pharmDx™ Kit and scored using the Allred scoring guideline described in the package insert. The method comparison data are presented (Table 2). Using these respective scoring guidelines, Anti-PR, Clone PgR 636 was concordant with the PR antibody component of Dako ER/PR pharmDx™ Kit, exhibiting values for overall, positive and negative agreement of 94.5%, 95.8% and 93.1%, respectively. Both assays were compared when scored using the ASCO/CAP guidelines (Table 3). Study results demonstrate a substantial degree of equivalency to the predicate device.

Reproducibility: Anti-PR, Clone PgR 636 reproducibility testing was performed in three testing laboratories over five non-consecutive days on 21 unique breast cancer specimens, and scored according to ASCO/CAP guidelines (≥1% cut-off) for a total of 315 evaluations. Site to site reproducibility of the assay is detailed (Table 4, Table 5, and Table 6). The average positive and average negative percent agreement calculations support the highly reproducible results of the PR (PgR 636) assay when used for the determination of PR status in a clinical setting.

| Anti-PR Component of ER/PR pharmDx™ Kit | | | | |
|-----------------------------------------|----------|----------|----------|-------|
| Anti-PR,<br>Clone PgR<br>636 | | Positive | Negative | Total |
| | Positive | 115 | 8 | 123 |
| | Negative | 5 | 108 | 113 |
| | Total | 120 | 116 | 236 |

Table 2. Agreement between Anti-PR, Clone PgR 636 (ASCO/CAP) and Anti-PR Component of ER/PR pharmDx™ Kit (Allred)

Positive Percent Agreement = 95.8% (95% Cl: 91.1-96.8) Negative Percent Agreement = 93.1% (95% CI: 90.5-96.7) Overall Percent Agreement = 94.5% (95% CI: 90.8-96.8)

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Image /page/4/Picture/1 description: The image shows the logo for Dako, an Agilent Technologies company. The logo consists of a stylized black droplet shape to the left of the word "Dako" in a bold, sans-serif font. Below the word "Dako" is the text "An Agilent Technologies Company" in a smaller, sans-serif font.

Analytical specificity: Anti-PR, Clone PgR 636 immunoreactivity was tested on the recommended panel of normal tissues (Table 1). All tissues were formalin-fixed, paraffinembedded, and stained with Anti- PR, Clone PoR 636 according to the instructions in the package insert. Cytoplasmic staining was observed with Anti-PR, Clone PgR 636 in several different tissue elements including epithelium, stroma, interstitial cells and inflammatory cells. While cytoplasmic staining was observed, it is not considered diagnostic per the intended use of this antibody.

Precision: Serial sections from each of 12 different FFPE blocks of breast carcinoma, representing a dynamic range of PR expression, were collected for testing. Testing was performed as follows:

Intra-run precision: Following the standard EnVision™ FLEX+, High pH protocol, three sections from each tissue block were stained with Anti-PR, Clone PgR 636. Concurrently, one section from each block was stained with a negative control reagent.

Inter-run precision: Staining one section from each tissue block, the above procedure was repeated on five non-consecutive days. Concurrently, one section from each tissue block was stained with a negative control reagent.

Inter-instrument precision: Staining a total of three sections from each tissue block, the above procedure was performed on three different Autostainer instruments by three different operators. Concurrently, one slide from each tissue block was stained with a negative control reagent.

Precision experiments with Anti-PR, Clone PgR 636 yielded consistent results with intrarun, inter-run and inter-instrument testing. Consistent test conditions were maintained throughout the study, and reagents were stored at 2-8 ℃ between test runs.

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Image /page/5/Picture/1 description: The image shows the logo for Dako, an Agilent Technologies company. The logo consists of a stylized symbol to the left of the word "Dako" in a bold, sans-serif font. Below the word "Dako" is the text "An Agilent Technologies Company" in a smaller font. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.

# Table 1. Summary of Anti-PR, Clone PgR 636 Normal Tissue Reactivity

| Tissue Type (# tested) | Positive Tissue Elements |
|------------------------|---------------------------------------------------------------------------------------------------|
| Adrenal (3) | 1/3 cells in glomerulosa region (50%), nuclear<br>1/3 cells in glomerulosa region (50%), nuclear |
| Bone marrow (3) | 0/3 |
| Breast (3) | 2/3 Glandular epithelial cells (50-90%), nuclear |
| Cerebellum (3) | 0/3 |
| Cerebrum (3) | 1/3 Meningial cells (100%), nuclear |
| Cervix (3) | 3/3 Epithelial cells (50-90%), nuclear<br>3/3 Stroma, including inflammatory cells (50%), nuclear |
| Colon (3) | 1/3 Lymphoid/inflammatory cells (10%), nuclear<br>1/3 Lympoid/inflammatory cells (10%), nuclear |
| Esophagus (3) | 1/3 Stromal cells (50%), nuclear |
| Kidney (3) | 3/3 Interstitial cells (1-5%), nuclear |
| Liver (3) | 0/3 |
| Lung (3) | 2/3 Interstitial cells (1-10%), nuclear<br>2/3 Inflammatory cells (1-10%), nuclear |
| Mesothelial cells (2) | 0/2 |
| Muscle, cardiac (3) | 3/3 Myocytes (30%), peri-nuclear |
| Muscle, skeletal (3) | 0/3 |
| Nerve, peripheral (3) | 0/3 |
| Ovary (3) | 3/3 Stromal cells (50-70%), nuclear |
| Pancreas (3) | 2/3 Islets of Langerhans (50-90%), nuclear |
| Parathyroid (3) | 3/3 Glandular epithelial cells (1-10%), nuclear |
| Pituitary (3) | 3/3 Pituitary glandular cells (1-40%), nuclear |
| Prostate (3) | 3/3 Stromal cells (30-80%), nuclear |
| Salivary gland (3) | 3/3 Glandular epithelial cells (<1%-60%), nuclear |
| Skin (3) | 0/3 |
| Small intestine (3) | 3/3 Stromal and inflammatory cells (30-50%), nuclear |
| Spleen (3) | 0/3 |
| Stomach (3) | 1/3 Interstitial cells (20%), nuclear |
| Testis (3) | 3/3 Interstitial cells (5-80%), nuclear |
| Thymus (3) | 0/3 |
| Thyroid (3) | 0/3 |
| Tonsil (3) | 0/3 |
| Uterus (2) | 2/2 Glandular epithelial cells (100%), nuclear<br>2/2 Myometrial stromal cells (100%), nuclear |

In addition to the testing referenced above, additional nonclinical studies in support of the substantial equivalence of Anti-PR, Clone PgR 636 include lot-to-lot and stability testing. An additional study is referenced: Analytical sensitivity for antibody characterization, established for PgR 636 concentrate in K020023. Summaries of all performance testing are provided in the Executive Summary of this 510(k). Full reports of all performance testing are provided in the Performance Testing (Bench) section of this 510(k).

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Image /page/6/Picture/0 description: The image shows the logo for Dako, which is "An Agilent Technologies Company". The logo consists of a stylized graphic to the left of the word "Dako". The text "An Agilent Technologies Company" is located below the word "Dako".

### 5.9 Conclusion

Based on the information provided in this premarket notification, Dako concludes that the FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-touse (Link) Antibody IHC assay is safe, effective, and substantially equivalent to the predicate device PR component of the Dako ER/PR pharmDx™ Kit in its indication for use, device design, materials, performance characteristics, and operational principles.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

### December 9, 2013

Dako North America, Inc Jennifer Michelle Chambers 6392 Via Real Carpinteria, CA 93013

Re: K130861

Trade/Device Name: Dako FLEX Monoclonal Mouse Anti-Human Progesterone Receptor,

Clone PgR 636, Ready-to-Use, (Link)

Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: II Product Code: MXZ Dated: November 8, 2013 Received: November 12, 2013

## Dear Ms. Chambers:

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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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Page 2-Ms. Chambers

: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

> If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/Resourcesfor You/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K 1 3086 I

## Device Name

:

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (Link)

Indications for Use (Describe) For in vitro diagnostic use.

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use, (LINK) is intended for use in immunohistochemistry with EnVision™ FLEX +, High pH visualization kit together with the Autostainer Link 48 instrument to semiquantitatively detect human progesterone receptor in formalin fixed, paraffin embedded human breast carcinoma. This antibody labels progesterone receptor positive cells and is useful in the assessment of progesterone 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY Section and the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the mail of the ma : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature,

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. . . . . ..

**FORM FDA 3881 (9/13)**

PSC Pablishing berriors (jul) 44 14723 用

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

.