(91 days)
Not Found
No
The summary describes an antibody and automated staining system for immunohistochemistry, with the interpretation performed by a qualified pathologist using light microscopy. There is no mention of AI or ML being used for image analysis, interpretation, or any other function of the device.
No
This device is for in vitro diagnostic use, intended to identify human progesterone receptor in tissue primarily to aid in the management and prognosis of breast cancer. It does not directly provide therapy.
Yes
The text explicitly states "For in vitro diagnostic use" and "Progesterone Receptor Clone (16) is indicated as an aid in the management, prognosis and prediction of therapy outcome of breast cancer."
No
The device is a monoclonal antibody (a biological reagent) used in immunohistochemical staining. While it is used with automated systems that have software components, the device itself is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states "For in vitro diagnostic use."
- Purpose: The device is intended for the qualitative identification of human progesterone receptor in tissue samples using immunohistochemical staining. This is a laboratory test performed on biological specimens outside of the body.
- Clinical Context: The intended use describes its role as an "aid in the management, prognosis and prediction of therapy outcome of breast cancer," which is a clear diagnostic application.
- Intended User: The interpretation is to be performed by a "qualified pathologist," indicating a clinical diagnostic setting.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ready-to-Use Format
For in vitro diagnostic use.
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) is a monoclonal antibody intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX or BOND-III systems. Progesterone Receptor Clone (16) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.
Progesterone Receptor 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 of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Progesterone Receptor Clone (16) is optimized for use on the Leica Biosystems automated BOND-MAX or BOND-III systems using the BOND Polymer Refine Detection kit.
Concentrated Liquid Antibody Format
For in vitro diagnostic use.
Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone (16) (Concentrated Liquid Antibody Format) 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. Progesterone Receptor Clone (16) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.
Progesterone Receptor Clone (16) Monoclonal Antibody (Concentrated Liquid Antibody Format) 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.
Product codes
MXZ
Device Description
Progesterone Receptor (16) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant. This antibody is utilized to perform a qualitative immunohistochemical (IHC) assay to identify Progesterone Receptor expression in human breast cancer tissue routinely processed and paraffin-embedded for histological examination.
Progesterone Receptor (PGR) Clone 16 Primary Antibody is provided in a Ready-to-Use (RTU) and a concentrated liquid format. The RTU format is supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin™ 950 as a preservative and is provided in two volumes (7 mL and 30 mL). The total protein concentration is approximately 10 mg/mL and the total antibody concentration is greater than or equal to 1 mg/L as determined by ELISA. The RTU format is optimally diluted for use on the automated BOND-MAX and BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). The concentrated liquid format is provided so that customers may utilize manual staining protocols. The concentrated liquid format is a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. The total protein concentration is determined on a per batch basis and is described on the vial label, and the antibody concentration is greater than or equal to 324.0 mg/L as determined by ELISA.
The BOND-MAX and BOND-III instruments are fully automated slide stainers that perform automated deparaffinization (dewaxing), antigen retrieval, immunohistochemistry (IHC) staining/in situ hybridization (ISH) staining, and counterstaining. The major components of the BOND staining platforms are the processing module, computer (BOND controller), handheld ID scanner, and slide label printer. The BOND staining platforms are composed of a number of discrete software components including the BOND application software, BOND instrument/processing module software, BOND service software, and Laboratory interface system - integration package (LIS-IP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
light microscopy
Anatomical Site
human progesterone receptor in formalin-fixed, paraffin-embedded tissue; breast cancer
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified pathologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Immunoreactivity:
- Evaluation on 118 normal tissues cases. Characteristic staining was observed in various tissues, including endometrial, cervical ovarian, myometrial cells, and normal breast ductal cells. Negative staining was observed in certain tissues (e.g., adrenal, bone marrow, brain). Positive staining was also observed in occasional stromal cells, lymphocytes, acinar cells, renal tubular cells, hypophyseal cells, and islet cells.
- Evaluation on a range of tumor tissue cases. Intense staining was observed in fibroadenomas of the breast, an endometrioid adenocarcinoma of the ovary, and a follicular papillary adenocarcinoma of the thyroid. Moderate staining was observed in a fibroblastic meningioma and a small cell carcinoma of the lung. Weak staining was observed in a malignant meningioma and a follicular carcinoma of the thyroid. Variable staining was observed in adenocarcinomas of the endometrium. Percentage of positive cells varied.
-
Precision (Repeatability & Reproducibility):
- Intra-run Repeatability:
- Study type: Intra-run Repeatability
- Sample size: Six unique breast tumor tissue cases (2 high PR, 1 low PR, 3 negative PR), 9 slides per case in two runs, total 54 assessments.
- Key results: Overall Percent Agreement (OPA) was 96.2% (51/53; 95% CI: 87.2% to 99.0%), Positive Percent Agreement (PPA) of 96.3% (26/27; 81.7% - 99.3%), and Negative Percent Agreement (NPA) of 96.2% (25/26; 81.1% - 99.3%).
- Inter-day, Inter-instrument, Inter-lot Repeatability:
- Study type: Inter-day, Inter-instrument, Inter-lot Repeatability
- Sample size: 27 unique breast tumor tissue cases (9 high PR, 5 low PR, 13 negative PR), 18 slides per case in 21 runs, total 486 assessments.
- Key results:
- Inter-day repeatability: OPA 98.8% (479/485; 95% CI: 97.3% - 99.4%), PPA 100% (198/198; 98.1% - 100%), NPA 97.9% (281/287; 95.5% - 99.0%).
- Inter-instrument repeatability: OPA 98.8% (479/485; 95% CI: 97.3% - 99.4%), PPA 100% (198/198; 98.1% - 100%), NPA 97.9% (281/287; 95.5% - 99.0%).
- Inter-lot repeatability: OPA 98.8% (479/485; 95% CI: 97.3% - 99.4%), PPA 100% (198/198; 98.1% - 100%), NPA 97.9% (281/287; 95.5% - 99.0%).
- All repeatability testing met acceptance criteria.
- Reproducibility (Inter-Laboratory):
- Study type: Reproducibility Study
- Sample size: 135 unique FFPE breast tumor tissue cases, conducted at 3 sites over 5 non-consecutive days, total 1209 evaluations. Scored according to ASCO/CAP guidelines (≥1% cut-off).
- Key results: The average positive, and overall agreement was 96.2%, 95.7%, and 95.9%, respectively.
- Reproducibility (Inter-Pathologist):
- Study type: Inter-Observer Reproducibility
- Sample size: 1215 slides (405 per pathologist) scored by 3 pathologists.
- Key results: The average positive, negative, and overall agreement was 94.1%, 93.4% and 93.7%, respectively.
- All reproducibility studies met acceptance criteria.
- Intra-run Repeatability:
-
Method Comparison:
- Study type: Method Comparison
- Sample size: Testing performed at 3 sites.
- Key results: The positive, negative and overall agreement for PR (16) staining using the BOND-III (Subject Device) compared to BOND-MAX (Predicate Device) was 95.5%, 95.7% and 95.6%, respectively. These results indicate PR (16) staining using the BOND-III is comparable to PR (16) staining using the BOND-MAX. The method comparison study results met acceptance criteria.
-
Stability:
- Study type: Stability
- Sample size: Three lots for real-time stability tests, one lot for transport tests.
- Key results: Product shelf-life is conservatively set at 18 months, unchanged from the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Intra-run Repeatability:
- OPA: 96.2% (95% CI: 87.2% to 99.0%)
- PPA: 96.3% (81.7% - 99.3%)
- NPA: 96.2% (81.1% - 99.3%)
- Inter-day, Inter-instrument, Inter-lot Repeatability:
- OPA: 98.8% (95% CI: 97.3% - 99.4%)
- PPA: 100% (98.1% - 100%)
- NPA: 97.9% (95.5% - 99.0%)
- Inter-Laboratory Reproducibility:
- All Labs APA: 96.2% (95% CI: 94.5% -97.6%)
- All Labs ANA: 95.7% (95% CI: 93.9% -97.3%)
- All Labs AOA: 95.9% (95% CI: 94.3% -97.4%)
- Inter-Pathologist Reproducibility:
- All Pathologists APA: 94.1% (95% CI: 92.0% -95.8%)
- All Pathologists ANA: 93.4% (95% CI: 91.1% -95.3%)
- All Pathologists AOA: 93.7% (95% CI: 91.7% -95.5%)
- Method Comparison (Subject Device vs. Predicate Device):
- Positive Percent Agreement = 95.5% (95% CI: 91.9%-97.5%)
- Negative Percent Agreement = 95.7% (95% CI: 92.2%-97.6%)
- Overall Percent Agreement = 95.6% (95% CI: 93.3%-97.1%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.1860 Immunohistochemistry reagents and kits.
(a)
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.(b)
Classification of immunohistochemistry devices. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. This exemption applies to IHC's that provide the pathologist with adjunctive diagnostic information that may be incorporated into the pathologist's report, but that is not ordinarily reported to the clinician as an independent finding. These IHC's are used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.(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.
(3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
(c)
Date of PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See § 864.3.
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March 06, 2020
Leica Biosystems Newcastle Ltd. % Zhijun (Julie) Pan Manager, Regulatory Affairs and Submissions Leica Biosystems 38 Cherry Hill Drive Danvers, MA 01923
Re: K193393
Trade/Device Name: BOND Ready-to-Use Primary Antibody Progesterone Receptor (16). Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format) Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry Reagents And Kits Regulatory Class: Class II Product Code: MXZ Dated: December 5, 2019 Received: December 6, 2019
Dear Zhijun (Julie) Pan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Soma Ghosh, Ph.D. Chief Molecular Pathology and Cytology Branch Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K193393
Device Name
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16),
Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone (16) (Concentrated Liquid Antibody Format)
Indications for Use (Describe)
Ready-to-Use Format
For in vitro diagnostic use.
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) is a monoclonal antibody intended to the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-III systems. Progesterone Receptor Clone (16) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.
Progesterone Receptor 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 of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Progesterone Receptor Clone (16) is optimized for use on the Leica Biosystems automated BOND-MAX or BOND-III systems using the BOND Polymer Refine Detection kit.
Concentrated Liquid Antibody Format
For in vitro diagnostic use.
Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone (16) (Concentrated Liquid Antibody Format) 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. Progesterone Receptor Clone (10) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.
Progesterone Receptor Clone (16) Monoclonal Antibody (Concentrated Liquid Antibody Format) 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.
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)
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SECTION 5 510(k) SUMMARY
This Premarket Notification Submission (510(k)) Summary is prepared in accordance with 21 CFR 807.92.
I. Submitter Information
| Sponsor Name: | Leica Biosystems Newcastle Ltd |
|---|---|
| Sponsor Address: | Balliol Business Park West |
| Benton Lane | |
| Newcastle upon Tyne | |
| UK | |
| NE12 8EW | |
| Sponsor Telephone: | +44 191 215 0567 |
| Sponsor Fax: | +44 191 215 1152 |
| Contact Person: | Zhijun (Julie) Pan, MD, PhD, RAC |
| Manager, Regulatory Affairs and Submissions | |
| Leica Biosystems | |
| Contact Email: | Zhijun.pan@leicabiosystems.com |
| Contact Telephone: | 978-578-5436 |
| Date Summary Prepared: | November 22, 2019 |
II. Device
| Trade (Proprietary) Name: | BOND Ready-to-Use Primary Antibody Progesterone
Receptor (16),
Novocastra Liquid Mouse Monoclonal Antibody Progesterone
Receptor Clone (16) (Concentrated Liquid Antibody Format) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common (Usual) Name: | Immunohistochemistry Assay, Antibody, Progesterone
Receptor |
| Regulation Number: | 21 CFR 864.1860 |
| Regulation Name: | Immunohistochemistry reagents and kits |
| Regulatory Class: | II |
| Product Code: | MXZ |
| Product Panel: | 88 (Pathology) |
III. Predicate Device
| Device Name: | BOND™ Ready-to-Use Primary Antibody Progesterone
Receptor (16),
Novocastra™ Liquid Mouse Monoclonal Antibody Progesterone
Receptor Clone 16 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device 510(k): | K171753 |
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IV. Device Description
Progesterone Receptor (16) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant. This antibody is utilized to perform a qualitative immunohistochemical (IHC) assay to identify Progesterone Receptor expression in human breast cancer tissue routinely processed and paraffin-embedded for histological examination.
Progesterone Receptor (PGR) Clone 16 Primary Antibody is provided in a Ready-to-Use (RTU) and a concentrated liquid format. The RTU format is supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin™ 950 as a preservative and is provided in two volumes (7 mL and 30 mL). The total protein concentration is approximately 10 mg/mL and the total antibody concentration is greater than or equal to 1 mg/L as determined by ELISA. The RTU format is optimally diluted for use on the automated BOND-MAX and BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). The concentrated liquid format is provided so that customers may utilize manual staining protocols. The concentrated liquid format is a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. The total protein concentration is determined on a per batch basis and is described on the vial label, and the antibody concentration is greater than or equal to 324.0 mg/L as determined by ELISA.
The BOND-MAX and BOND-III instruments are fully automated slide stainers that perform automated deparaffinization (dewaxing), antigen retrieval, immunohistochemistry (IHC) staining/in situ hybridization (ISH) staining, and counterstaining. The major components of the BOND staining platforms are the processing module, computer (BOND controller), handheld ID scanner, and slide label printer. The BOND staining platforms are composed of a number of discrete software components including the BOND application software, BOND instrument/processing module software, BOND service software, and Laboratory interface system - integration package (LIS-IP).
V. Intended Use
Ready-to-Use Format
For in vitro diagnostic use.
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) is a monoclonal antibody intended to be used for the qualitative identification by light microscopy of human progesterone receptor in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND-MAX or BOND-III systems. Progesterone Receptor Clone (16) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.
Progesterone Receptor 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 of the patient's clinical history and other diagnostic tests by a qualified pathologist.
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Image /page/5/Picture/1 description: The image shows the logo for Leica Biosystems. The word "Leica" is written in a stylized red font, with the letters connected in a flowing script. Below "Leica" is the word "BIOSYSTEMS" in a smaller, sans-serif red font. The logo is simple and clean, with a focus on the company name.
Progesterone Receptor Clone (16) is optimized for use on the Leica Biosystems automated BOND-MAX or BOND-III systems using the BOND Polymer Refine Detection kit.
Concentrated Liquid Antibody Format
For in vitro diagnostic use.
Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone (16) (Concentrated Liquid Antibody Format) 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. Progesterone Receptor Clone (16) specifically binds to the progesterone receptor antigen located in the nucleus of progesterone receptor positive normal and neoplastic cells.
Progesterone Receptor Clone (16) Monoclonal Antibody (Concentrated Liquid Antibody Format) 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.
VI. Comparison of Technological Characteristics with the Predicate Device
The BOND Ready-to-Use Primary Antibody Progesterone Receptor (16) and Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 is substantially equivalent to its predicate device with the same name (except removal of the TM trade mark), cleared under K171753. The subject device adds the BOND-III instrument staining platform and the BOND Ready-to-Use (RTU) Primary Antibody (30 mL) to the existing device. The similarities and differences between the subject device and the predicate device are summarized in Table 1 below.
| Item | Subject Device | Predicate Device
K171753 |
|---------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Intended Use | Qualitative identification of
human Progesterone Receptor
in breast cancer patients | Same |
| Antibody Type | Mouse monoclonal | Same |
| Isotype | IgG1 | Same |
| PR Clone | 16 | Same |
| Immunogen | A prokaryotic recombinant protein
corresponding to the N-terminal
region of the A form of the human
progesterone receptor | Same |
| Storage | 2-8 °C | Same |
| Technology | Immunohistochemistry | Same |
Table 1. Comparison of Technological Characteristics with the Predicate Device
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Image /page/6/Picture/1 description: The image shows the logo for Leica Biosystems. The word "Leica" is written in a stylized red font. Below the word "Leica" is the word "BIOSYSTEMS" written in a smaller, sans-serif font, also in red. The logo is simple and clean, with a focus on the company name.
| Tissue Type | Formalin-fixed paraffin-
embedded breast cancer tissue | Same |
|----------------------------------------------------------|-----------------------------------------------------------|------------------|
| Staining Pattern | Nuclear | Same |
| Staining Protocol | IHC Protocol F | Same |
| Differences | | |
| Item | Subject Device | Predicate Device |
| Staining Instrument | BOND-III & BOND-MAX | BOND-MAX |
| RTU Antibody Progesterone
Receptor (16) Configuration | 7 mL & 30 mL | 7 mL |
VII. Performance Data
Immunoreactivity
The specificity of PR (16) was evaluated on 118 normal tissues cases. Characteristic staining was observed in the nuclei of cells that express high levels of the protein, a proportion of endometrial, cervical ovarian and myometrial cells, and normal breast ductal cells. Negative tissues included adrenal, bone marrow, brain (cerebellum), brain (cerebrum), esophagus, heart, liver, mesothelial cells, parathyroid, peripheral nerve, skeletal muscle, skin, small intestine, spleen, spinal cord, stomach, testis, thymus, and thyroid. Positive staining was also observed in occasional stromal cells of the bladder, lung and prostate, occasional lymphocytes in colon and rectum, acinar cells in salivary/submandibular gland, occasional renal tubular cells in the kidney, occasional hypophyseal cells of the pituitary and occasional islet cells of the pancreas.
PR (16) was evaluated on a range of tumor tissue cases. Intense staining was observed in fibroadenomas of the breast, an endometrioid adenocarcinoma of the ovary and a follicular papillary adenocarcinoma of the thyroid. Moderate staining was observed in a fibroblastic meningioma and a small cell carcinoma of the lung. Weak staining was observed in a malignant meningioma and a follicular carcinoma of the thyroid. Variable staining was observed in adenocarcinomas of the endometrium. The percentage of positive cells was low (1-10%) in the follicular papillary adenocarcinoma and follicular carcinoma of the thyroid, and high (>10%) in the fibroblastic meningioma, malignant meningioma, fibroadenomas of the breast, small cell carcinoma of the lung, endometrioid adenocarcinoma of the ovary and adenocarcinomas of the endometrium.
Precision (Repeatability & Reproducibility)
Intra-run Repeatability
Six unique breast tumor tissue cases were stained as part of intra-run repeatability testing. Of the six tissues, two had PR high expression (>10% tumor cells), 1 PR low expression (1-10% tumor cells), and 3 PR negative (10% tumor cells), 5 PR low expression (1-10% tumor cells), and 13 PR negative (