(352 days)
Not Found
No
The summary describes an immunohistochemistry assay and an automated staining instrument, with no mention of AI or ML for image analysis or interpretation.
No
This device is for in vitro diagnostic use, intended to detect human estrogen receptor in tissue sections to assist in assessing estrogen receptor status in breast carcinomas, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." and describes its use in assessing estrogen receptor status in breast cancer, which is a diagnostic purpose.
No
The device is an antibody reagent intended for use in immunohistochemistry with a specific instrument. While it mentions software controlling the automated staining process, the device itself is a biological reagent, not software.
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 Test: The device is an antibody used in immunohistochemistry (IHC) to detect a specific protein (estrogen receptor a) in tissue samples. This is a laboratory test performed on biological specimens outside of the body, which is the definition of an in vitro diagnostic.
- Purpose: The purpose is to aid in the assessment of estrogen receptor status in human breast carcinomas, which is a crucial diagnostic and prognostic factor in breast cancer treatment. This directly contributes to a clinical diagnosis.
- Intended User: The intended user is a "qualified pathologist," who is a medical professional responsible for interpreting laboratory tests for diagnostic purposes.
The information provided clearly indicates that this device is designed and intended for use in a laboratory setting to perform a diagnostic test on patient samples.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use.
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis), is intended for use in immunohistochemistry with the EnVision FLEX visualization system together with the Dako Omnis instrument to qualitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody binds estrogen receptor a expressing 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. This antibody is intended to be used after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains.
Product codes (comma separated list FDA assigned to the subject device)
MYA
Device Description
The FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis) antibody is utilized to perform a qualitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in fixed human breast cancer tissues routinely processed and paraffin-embedded for histological examination.
The design of the proposed device is based on the design of its predicate FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α. Clone EP1, Ready-to-Use (Link) with adaptation of the product configuration, to be used on the Dako Omnis Instrument instead of the Autostainer Link 48 Instrument.
The antibody is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The antibody is intended for automated immunohistochemical (IHC) slide staining with the Dako Omnis Instrument and the software performing and controlling the automated slide staining process is validated for its intended use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human 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)
Performance characteristics were evaluated to determine its analytical specificity for normal tissue and reproducibility to control intra run, inter lot, inter-laboratory and interobserver variations. The device was also evaluated in a concordance study to establish equivalence to the predicate device. All results from performance studies confirm that GA084 meets its acceptance criteria and is substantial equivalent to its predicate device IR084.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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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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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2017
Dako Denmark A/S Lasse Post Møller Pathology Regulatory Affairs Manager Produktionsvej 42 DK-2600 Glostrup, Denmark
Re: K170028
Trade/Device Name: FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Readyto-Use (Dako Omnis) Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: Class II Product Code: MYA Dated: December 28, 2017 Received: January 3, 2017
Dear Lasse Post Møller:
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 and Part 809); medical device 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
1
Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Reena Philip -S
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
Enclosure
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Indications for Use
510(k) Number (if known) K170028
Device Name
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis)
Indications for Use (Describe)
For in vitro diagnostic use.
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis), is intended for use in immunohistochemistry with the EnVision FLEX visualization system together with the Dako Omnis instrument to qualitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody binds estrogen receptor a expressing 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. This antibody is intended to be used after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
Traditional Premarket Notification Submission (510(k)) Summary Prepared in accordance with 21 CFR 807.92
Sponsor Name and Address
Dako Denmark A/S Produktionsvej 42 2600 Glostrup, Denmark
Establishment registration No: 9610099
Contact
Lasse Post Møller Dako Denmark A/S Produktionsvej 42 2600 Glostrup, Denmark Telephone: +45 5167 6362 Telefax: +45 8830 5998 Email: lasse.moller@agilent.com
Date Summary Prepared
December 21, 2017
Device Name(s)
| Trade name(s) | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α,
Clone EP1, Ready-to-Use (Dako Omnis) |
|-------------------|------------------------------------------------------------------------------------------------|
| Product code: | GA084 |
| Common name | Anti-Human ER a, Clone EP1 (Dako Omnis) |
| Classification: | Class II (21 CFR 864.1860) |
| FDA Product Code: | MYA |
Predicate Device:
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| Trade name (s): | Dako Monoclonal Rabbit Anti-Human Estrogen Receptor α, |
|---|---|
| Clone EP1, FLEX, Ready-to-Use (RTU) Link | |
| FDA Product code: | MYA |
| Classification: | Class II (21 CFR 864.1860) |
| Device Cleared in Premarket notification K120663. |
Device Description
The FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis) antibody is utilized to perform a qualitative immunohistochemical (IHC) assay to identify estrogen receptor (ER) expression in fixed human breast cancer tissues routinely processed and paraffin-embedded for histological examination.
The design of the proposed device is based on the design of its predicate FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α. Clone EP1, Ready-to-Use (Link) with adaptation of the product configuration, to be used on the Dako Omnis Instrument instead of the Autostainer Link 48 Instrument.
The antibody is provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide. The antibody is intended for automated immunohistochemical (IHC) slide staining with the Dako Omnis Instrument and the software performing and controlling the automated slide staining process is validated for its intended use.
Intended Use:
For in vitro diagnostic use.
FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis), is intended for use in immunohistochemistry with the EnVision FLEX visualization system together with the Dako Omnis instrument to qualitatively detect human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer. The antibody binds estrogen receptor a expressing cells and is useful in the assessment of estrogen receptor status in human breast carcinomas.
5
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. This antibody is intended to be used after the primary diagnosis of tumor has been made by conventional histopathology using nonimmunologic histochemical stains.
Substantial Equivalence
The proposed device, FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Dako Omnis), is claimed to be substantially equivalent to the predicate device FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link), also referred to by its product code IR084. The predicate device is cleared for the US market in the premarket notification K120663.
Both products specifically bind to estrogen receptor (ER) proteins located in the nuclei of cells. Both products require similar detection chemistry principles for visualization of antigens, and both aid in the prognosis of breast carcinoma. Both products have the same intended use, staining steps and scoring guideline for interpretation.
All differences between the proposed device GA084 and its predicate are related to their use with different slide staining instruments, see details in the comparison table below.
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | Detection of Estrogen | |
| Receptor α Protein | same | |
| Antibody Type | Monoclonal, rabbit origin | Same |
| Isotype | IgG | Same |
| Clone | EP1 | Same |
| Staining Pattern | Nuclear | Same |
| Interpretation of results | Positive: ≥1% positive staining | |
| breast cancer cells | Same |
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| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Tissue Type | Formalin-fixed paraffin- | |
| embedded breast cancer | Same | |
| Technology | Immunohistochemistry | Same |
| Storage | 2-8 °C | Same |
| Differences | ||
|---|---|---|
| Item | Device | Predicate |
| Configuration | Pre-diluted Ready-to-use with | |
| Dako Omnis | Pre-diluted Ready-to-use | |
| with Autostainer Link 48 | ||
| Temperature | ||
| Control/Incubation | ||
| Temperature | Temperature controlled at | |
| 32°C $\u00b1$ 2°C | No temperature control | |
| (ambient temperature) | ||
| Antibody Concentration | 15 µg/mL | 3.7 µg/mL |
| Antibody Incubation Time | 10 minutes | 20 minutes |
| Staining | Dynamic gap staining: | |
| Reagent is applied and | ||
| distributed across slide via | ||
| active slide lids which enable | ||
| capillary force spreading | Open slide staining: Reagent | |
| is applied and distributed | ||
| across slide via gravitational | ||
| spreading | ||
| Vial | Dako Omnis Large Vial, 30 mL | Automation Vial, 25mL |
| Cap | Dako Omnis Closure including | |
| septum | White Nalgene Cap | |
| Deparaffinization | On-board Dako Omnis with | |
| Clearify | EnVision FLEX High pH on | |
| external PT Module | ||
| Pre-Treatment (Antigen | ||
| Retrieval) | EnVision FLEX High pH (30 | |
| minute heat-induced Epitope | ||
| retrieval) | EnVision FLEX High pH (20 | |
| minute heat-induced Epitope | ||
| retrieval) | ||
| Visualization | EnVision FLEX (Chromogen 5 | |
| minutes) | EnVision FLEX (Chromogen 2 | |
| x 5 minutes) |
The proposed device is evaluated to be substantially equivalent to its predicate device and does not introduce any new issues for safety and effectiveness.
Performance Characteristics
Performance characteristics were evaluated to determine its analytical specificity for normal tissue and reproducibility to control intra run, inter lot, inter-laboratory and interobserver variations. The device was also evaluated in a concordance study to establish equivalence to the predicate device. All results from performance studies confirm that
7
GA084 meets its acceptance criteria and is substantial equivalent to its predicate device IR084.
Therefore, based on the information provided in this premarket notification, we conclude that, FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1, Ready-to-Use (Dako Omnis) is safe, effective and substantially equivalent to the predicate device in the indication for use, device design, materials, operational principles, and intended use.