(256 days)
Not Found
No
The summary describes an immunohistochemistry antibody and an automated staining platform, with the interpretation performed by a qualified pathologist. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
Explanation: The device is an in vitro diagnostic intended for semiquantitative detection of human progesterone receptor in breast carcinoma for diagnostic purposes, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For in vitro diagnostic use" and is intended for use in immunohistochemistry to "semiquantitatively detect human progesterone receptor in formalin fixed, paraffin embedded human breast carcinoma" to assess "progesterone receptor status in human breast carcinomas." This directly indicates its role in diagnosing a medical condition.
No
The device is a monoclonal antibody (a biological reagent) intended for use in immunohistochemistry, which is a laboratory technique involving physical reagents and instruments. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
- Nature of the Device: The device is an antibody used in immunohistochemistry to detect a specific protein (progesterone receptor) in human tissue samples (formalin fixed, paraffin embedded human breast carcinoma). This process is performed outside of the living body ("in vitro") to aid in diagnosis.
- Intended Use: The intended use is to "semiquantitatively detect human progesterone receptor" and is "useful in the assessment of progesterone receptor status in human breast carcinomas." This directly relates to providing diagnostic information.
- Clinical Interpretation: The document mentions that the "clinical interpretation of any staining or its absence should be complemented by morphological studies... and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist." This highlights its role in the diagnostic process.
- Performance Studies: The document details performance studies like concordance and reproducibility, which are standard for evaluating the performance of IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" (K042884; PR component of the Dako ER/PR pharmDx™ Kit) is common in regulatory submissions for IVDs, indicating a comparison to an already cleared device.
All these factors strongly indicate that this device is intended for use in the diagnosis of disease and is therefore an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MXZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human breast carcinoma
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)
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.
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.
Concordance: Anti-PR, Clone PgR 636 testing was performed with EnVision™ FLEX+ and scored according to ASCO/CAP guidelines (≥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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Table 3. Agreement between Anti-PR, Clone PgR 636 (ASCO/CAP) and Anti-PR Component of ER/PR pharmDx™ Kit (ASCO/CAP)
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
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
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
Average Positive Percent Agreement = 95.7%
Average Negative Percent Agreement = 94.7%
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)
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.
0
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 |
| Carpinteria, CA 93013 USA | |
| Sponsor Telephone: | 805-566-6655 |
| Sponsor Fax: | 805-566-6688 |
| Establishment Registration: | 2022180 |
C
| Contact person: | Jennifer Michelle Chambers
MPA, MBA, CQA (ASQ) |
|---------------------------|---------------------------------------------------------|
| Contact title: | Regulatory Affairs Specialist, Dako North America, Inc. |
| Email Direct (preferred): | jennifer.chambers@dako.com |
| Telephone Direct: | 805-566-3036 |
| Date Summary Prepared: | March 22, 2013 |
5.2 Device Name
| Trade (proprietary): | FLEX Monoclonal Mouse Anti-Human Progesterone
Receptor, Clone PgR 636, Ready-to-Use, (Link) |
|----------------------|------------------------------------------------------------------------------------------------|
| Common (usual): | Anti-PR, Clone PgR 636 |
| Classification: | 21 CFR 864.1860: Immunohistochemistry (IHC)
Reagents and Kits (Class II) |
| FDA Device Code: | MXZ: Immunohistochemistry Assay, Antibody.
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 |
1
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, | ||||
| 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%
2
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.
3
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, | ||||
| Clone PgR | ||||
| 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)
4
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.
5
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 |
| 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 |
| 3/3 Stroma, including inflammatory cells (50%), nuclear | |
| Colon (3) | 1/3 Lymphoid/inflammatory cells (10%), nuclear |
| 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 |
| 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 ( 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/8/Picture/6 description: The image shows the text "Reena Balip -S" in a bold, sans-serif font. The words are arranged horizontally, with "Reena" on the left, followed by "Balip" in a slightly different style, and then "-S" on the right. The text is black against a white background, creating a clear contrast.
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
9
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,
Image /page/9/Picture/13 description: The image shows the text "Reena Philip -S" in a bold, sans-serif font. The word "Reena" is clearly legible, while "Philip" is stylized with a geometric pattern within the letters. The "-S" is smaller and positioned to the right of "Philip", completing the text string.
. . . . . ..
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.
.