BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody

K183102 · Leica Biosystems Newcastle, Limited · MXZ · Dec 7, 2018 · Hematology

Device Facts

• Record ID: K183102
• Device Name: BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
• Applicant: Leica Biosystems Newcastle, Limited
• Product Code: MXZ · Hematology
• Decision Date: Dec 7, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.1860
• Device Class: Class 2

Intended Use

Ready-to-Use Format Progesterone Receptor (16) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor (PR) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX system. Progesterone Receptor Clone (16) [PR (16)] specifically binds to the PR antigen located in the nucleus of PR positive normal and neoplastic cells. PR (16) 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. Concentrated Liquid Antibody Format. Progesterone Receptor (PGR) Clone 16 monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells. PGR Clone 16 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's clinical history and other diagnostic tests by a qualified pathologist.

Device Story

BOND™ RTU and Concentrated Liquid Mouse Monoclonal Antibody (Clone 16) are immunohistochemistry (IHC) reagents; used for qualitative identification of progesterone receptor (PR) in formalin-fixed, paraffin-embedded (FFPE) tissue sections. RTU format is optimized for automated BOND-MAX system; concentrated format is for manual or automated use. Pathologists use light microscopy to visualize nuclear staining in normal and neoplastic cells. Results serve as an aid in breast cancer management, prognosis, and therapy prediction. Clinical interpretation requires correlation with patient history, morphology, and other diagnostic tests.

Clinical Evidence

No clinical data. Verification and validation were limited to bench testing, including staining verification, EMC testing, hardware/firmware progression, and system integration/regression testing to ensure the modified hardware and software maintained performance equivalent to the predicate.

Technological Characteristics

Mouse monoclonal antibody (Clone 16) targeting human progesterone receptor. Reagents provided in Ready-to-Use (RTU) format for automated BOND-MAX system or as concentrated liquid. Principle of operation is immunohistochemical staining for light microscopy visualization of nuclear antigens in FFPE tissue.

Indications for Use

Indicated for qualitative identification of human progesterone receptor (PR) in formalin-fixed, paraffin-embedded breast tissue as an aid in management, prognosis, and prediction of therapy outcome for breast cancer patients.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 07, 2018

Zhijun (Julie) Pan, MD, PhD, RAC Manager, Regulatory Affairs and Submissions Leica Biosystems 38 Cherry Hill Drive Danvers, MA 01923

Re: K183102

Trade/Device Name: BOND™ Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) and Concentrated Liquid Mouse Monoclonal Antibody (Novocastra™) Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: Class II Product Code: MXZ Dated: November 3, 2018 Received: November 7, 2018

Dear Dr. Zhijun (Julie) Pan:

We have reviewed vour 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

{1}------------------------------------------------

803) for devices; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Soma Ghosh -S 2018.12.07 15:33:25 -05'00' 11.0.22 | | | |

for

Reena Philip, Ph.D. Director Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K183102

#### Device Name

BOND™ Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) and Concentrated Liquid Mouse Monocloral Antibody (Novocastra™)

### Indications for Use (Describe)

Ready-to-Use Format

Progesterone Receptor (16) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor (PR) in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX system. Progesterone Receptor Clone (16) [PR (16)] specifically binds to the PR antigen located in the nucleus of PR positive normal and neoplastic cells.

PR (16) 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.

Concentrated Liquid Antibody Format.

Progesterone Receptor (PGR) Clone 16 monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining. PGR Clone 16 specifically binds to the PGR antigen located in the nucleus of PGR positive normal and neoplastic cells.

PGR Clone 16 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's clinical history and other diagnostic tests by a qualified pathologist.

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

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."