(344 days)
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No
The summary describes a traditional immunohistochemistry assay and automated staining system, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is for in vitro diagnostic use, specifically for semi-quantitative detection of human estrogen receptor in tissue sections to assess estrogen receptor status in breast cancer, which aids in diagnosis and prognosis, not direct treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use," and describes its purpose as detecting human estrogen receptor in breast cancer tissues, which is a diagnostic application.
No
The device is a physical antibody reagent intended for use in immunohistochemistry, not a software program.
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 to "semi-quantitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer." This is a diagnostic test performed on biological samples (tissue sections) outside of the living body (in vitro).
- Clinical Interpretation: The "Intended Use" section mentions that the results are for "clinical interpretation" and should be evaluated by a "qualified pathologist" within the context of the patient's clinical history and other diagnostic tests. This reinforces its role in the diagnostic process.
- Device Description: The description details an "immunohistochemical (IHC) assay" used to "identify estrogen receptor (ER) expression in human breast cancer tissues." IHC is a common in vitro diagnostic technique.
All of these points align with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use.
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Readyto-Use, (LINK), is intended for use in immunohistochemistry with EnVision™ FLEX, High pH visualization kit together with Autostainer Link 48 to semiquantitatively detect human estrogen receptor in formalin-fixed, paraffinembedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.
The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Product codes (comma separated list FDA assigned to the subject device)
IR084, MYA
Device Description
Dako Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 (Dako Anti-Human ER a, clone EP1) antibody is utilized to perform a semi-quantitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The ER a antibody is available in Ready-to-Use (RTU) format and is optimized for use with Dako Automated stainer Link 48. The RTU Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 is provided in one vial of ready-to-use monoclonal rabbit antibody contains 12 ml of reagent provided in liguid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The working Ig concentration of the antibody is approximately 3.7 ug/mL. Total protein concentration is approximately 10mg/mL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human breast cancer, human breast carcinomas.
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)
Performance characteristics evaluated in support of the Dako Anti-Human ER o, clone EP1 IHC assay include results on specificity, sensitivity, reproducibility, and concordance testing. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate device listed above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
specificity, sensitivity, reproducibility, and concordance
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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Image /page/0/Picture/1 description: The image contains a logo and the word "Dakota". The logo is a stylized image of a flame or a drop of liquid, with a circular shape at the top and a pointed shape at the bottom. The word "Dakota" is written in a simple, sans-serif font, with the first letter capitalized and the rest in lowercase. The logo is positioned to the left of the word "Dakota".
510(k) Pre-Market Notification for Dako Anti-Human ER α Clone EP1
FEB 1 2 2013
7. 510(K) Summary
7.1.1 Assigned 510(k) Number
The assigned 510(k) number is K120663
7.2 Sponsor Name and Address
Dako North America, Inc 6392 Via Real Carpinteria, CA 93013 Phone: 1 805 566 6655 Fax: 1 805 566 6688
Establishment registration No: 2022180
7.3 Contact
Xiaolei Xu, Ph.D. Requlatory Affairs Manager E-mail: xiaolei.xu@dako.com Phone direct: 1 805 566 3013 Fax: 1 805 566 6688
Summary Prepared February 28, 2012 7.4
- Summary Revised Feb 4, 2013 7.5
7.6 Device Name(s)
Trade name(s)
Dako Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1, FLEX, Ready- to-Use (RTU) Link Product code: IR084
Common name(s) Classification:
Dako Anti-Human ER a, Clone EP1 Class II (21 CFR 864.1860)
Dako North America, Inc
1
Image /page/1/Picture/0 description: The image shows the logo for Dako. The logo consists of a stylized flame-like symbol on the left and the word "Dako" on the right. The flame symbol is dark and appears to be enclosed in an oval shape. The word "Dako" is in a simple, sans-serif font.
510(k) Pre-Market Notification for Dako Anti-Human ER a Clone EP1
7.7 Predicate Device:
ER a component of the Dako ER/PR pharmDx™ Kit (K042884)
7.8 Device Description
Dako Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 (Dako Anti-Human ER a, clone EP1) antibody is utilized to perform a semi-quantitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in human breast cancer tissues routinely processed and paraffin-embedded for histological examination. The ER a antibody is available in Ready-to-Use (RTU) format and is optimized for use with Dako Automated stainer Link 48. The RTU Monoclonal Rabbit Anti-Human Estrogen Receptor (ER) a, Clone EP1 is provided in one vial of ready-to-use monoclonal rabbit antibody contains 12 ml of reagent provided in liguid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The working Ig concentration of the antibody is approximately 3.7 ug/mL. Total protein concentration is approximately 10mg/mL.
7.9 Intended Use:
For in vitro diagnostic use.
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use, (LINK), is intended for use in immunohistochemistry with EnVision™ FLEX, High pH visualization kit together with Autostainer Link 48 to semi-quantitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.
The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
7.10 Substantial Equivalence
Dako Anti-Human ER q. clone EP1 Antibody IHC assay is substantially equivalent to the ER a component of the Dako ER/PR pharmDx™ Kit. Both products specifically bind to estrogen receptor proteins located in the nuclei of cells, these products require similar detection chemistry principles for visualization of the product, and both aid in
Dako North America, Inc
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Image /page/2/Picture/0 description: The image shows a logo with a stylized flame-like symbol on the left and the word "Dakota" on the right. The flame symbol is black and appears to be a stylized representation of a gas flame. The word "Dakota" is also in black and is written in a simple, sans-serif font. The logo is simple and clean, with a focus on the flame symbol and the company name.
510(k) Pre-Market Notification for Dako Anti-Human ER α Clone EP1
the prognosis of breast carcinoma. The difference in visualization between the predicate device and Anti-human ER a Antibody, Clone EP1 does not introduce new issues of safety and effectiveness.
7.11 Performance Characteristics:
Performance characteristics evaluated in support of the Dako Anti-Human ER o, clone EP1 IHC assay include results on specificity, sensitivity, reproducibility, and concordance testing. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate device listed above.
Therefore, based on the information provided in this premarket notification, Dako concludes that the device listed above is safe, effective and substantially equivalent to the predicate device in the indication for use, device design, materials, operational principles, and intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2013
Dako North America, Inc c/o Dr. Xiaolei Xu Regulatory Affairs Manager 6392 Via Real Carpinteria, California 93013
Re: K120663
Trade/Device Name: FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link)
Regulation Number: 21 CFR §864.1860
Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: II Product Code: MYA Dated: January 16, 2013 Received: January 24, 2013
Dear Dr. Xu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 – Dr. Xiaolei Xu
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Reena Philip -S
for
Maria M. Chan, Ph.D.
Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K120663
Device Name:
Monoclonal Rabbit Anti- Human Estrogen Receptor a, Clone EP1 FLEX Ready-to-Use (Link) Product Code IR084
Indications For Use:
For in vitro diagnostic use.
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Readyto-Use, (LINK), is intended for use in immunohistochemistry with EnVision™ FLEX, High pH visualization kit together with Autostainer Link 48 to semiquantitatively detect human estrogen receptor in formalin-fixed, paraffinembedded tissue sections of human breast cancer. The antibody labels estrogen receptor a-positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.
The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donne Rowe
Division Sign-Off
Citico of in Vitro Diagnostics and Radiological Health
5068KI K/20663
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