(119 days)
Not Found
No
The summary describes an immunohistochemical (IHC) assay kit for manual or automated use with DakoCytomation detection systems. There is no mention of AI or ML in the device description, intended use, or performance studies. The evaluation is based on light microscopy and semi-quantitative detection, which are standard IHC methods.
No
The device aids in identifying patients eligible for treatment and in prognosis and management, but it does not directly treat or cure a disease. It is a diagnostic tool.
Yes
The device is described as an "aid in identifying patients eligible for treatment... as well as an aid in the prognosis and management of breast cancer," and an "aid in the management, prognosis and prediction of outcome of breast cancer," which are all diagnostic purposes.
No
The device is described as an immunohistochemical (IHC) kit system, which involves physical reagents and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the assay is used to identify ER and PR expression in breast cancer tissues to aid in identifying patients eligible for treatment, as well as an aid in the prognosis and management of breast cancer. This is a diagnostic purpose performed in vitro (outside the body) on tissue samples.
- Device Description: The device is described as an immunohistochemical (IHC) kit system used to identify specific protein expression in tissue samples. This is a common method for in vitro diagnostic testing.
- Anatomical Site: The assay is performed on breast cancer tissues, which are biological specimens.
- Intended User / Care Setting: The intended user is a laboratory, which is where in vitro diagnostic tests are typically performed.
- Performance Studies: The document describes performance characteristics like specificity, sensitivity, reproducibility, and concordance, which are standard evaluations for IVD devices.
- Predicate Devices: The listed predicate devices are also IVD devices used for similar diagnostic purposes.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
The DakoCytomation ER/PR pharmDxTM assay is an immunohistochemical (IHC) kit system to identify human estrogen receptor (ER) and human progesterone receptor (PR) expression in breast cancer tissues routinely processed and paraffin-embedded for histological evaluation. ER/PR pharmDx specifically detects the ER alpha protein as well as the PR located in the cell nucleus of ER and/or PR-expressing cells.
ER/PR pharmDx is indicated as an aid in identifying patients eligible for treatment with antihormonal or aromatase inhibitor therapies, as well as an aid in the prognosis and management of breast cancer.
The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is intended for laboratory use as a semi-quantitative detection of progesterone receptor by light microscopy in routinely processed normal and pathological human paraffinembedded tissue. This antibody is indicated for use as an aid in the management, prognosis and prediction of outcome of breast cancer. The clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified individual.
Product codes
MYA, MXZ
Device Description
The DakoCytomation ER/PR pharmDx™ assay is a semi-quantitative immunohistochemical (IHC) kit system to identify estrogen receptor (ER) and progesterone receptor (PR) expression in normal and neoplastic tissues routinely processed and paraffin-embedded for histological expressing cells respectively.
ER/PR pharmDx assay is available in two configurations, both manual and automated and is optimized for use with DakoCytomation detection systems.
The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is a component of the ER/PR pharmDx kit, which will also be commercially available as a concentrate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast cancer tissues, normal and neoplastic tissues, normal and pathological human paraffinembedded tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory use
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 ER/PR pharmDx™ IHC kit and components include results on specificity, sensitivity, reproducibility, and concordance testing. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate devices listed above. Further, concordance testing between the DakoCytomation ER/PR pharmDx kit and the reference, Allred method, demonstrated substantially equivalent staining results (99% concordance).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
specificity, sensitivity, reproducibility, and concordance testing. 99% concordance.
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
FEB 1 5 2005
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______K042884
| Submitter: | DakoCytomation California, Inc.
6392 Via Real
Carpinteria, CA 93013
PH. 805.566.6655 FX. 805.566.0866
Establishment registration number: 2022180 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tiffany D. Almeroth, RAC
Sr. Regulatory Affairs Specialist
PH. 805.566.3041 |
| Date Summary Prepared: | September 30, 2004 |
| Device Name(s): | DakoCytomation ER/PR pharmDx™ Kit.
Immunohistochemistry kit.
(Code K1903/K1904) |
| | DakoCytomation Monoclonal Mouse Anti-Human Progesterone
Receptor, clone PgR 1294.
Antibody for immunoenzymatic staining.
(Code M3568) |
| Device Classification: | Class II, for prognostic immunohistochemical staining reagents
21 CFR 864.1860 |
| Panel: | Hematology and Pathology Devices Panel
Division of Clinical Laboratory Devices. |
| Predicate Devices: | Estrogen Receptor
• DakoCytomation Monoclonal Mouse Anti-Human
Estrogen Receptor, Clone 1D5, (K993957)
• Ventana ER clone 6F11, (K984567)
Progesterone Receptor
• DakoCytomation Monoclonal Mouse Anti-Human
Progesterone Receptor, Clone PgR 636, (K020023) |
Device Description:
The DakoCytomation ER/PR pharmDx™ assay is a semi-quantitative immunohistochemical (IHC) kit system to identify estrogen receptor (ER) and progesterone receptor (PR) expression in normal and neoplastic tissues routinely processed and paraffin-embedded for histological expressing cells respectively.
ER/PR pharmDx assay is available in two configurations, both manual and automated and is optimized for use with DakoCytomation detection systems.
1
The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is a component of the ER/PR pharmDx kit, which will also be commercially available as a concentrate.
Intended Use:
For In Vitro Diagnostic Use
The DakoCytomation ER/PR pharmDx™ assay is an immunohistochemical (IHC) kit system to identify human estrogen receptor (ER) and human progesterone receptor (PR) expression in breast cancer tissues routinely processed and paraffin-embedded for histological evaluation. ER/PR pharmDx specifically detects the ER alpha protein as well as the PR located in the cell nucleus of ER and/or PR-expressing cells.
ER/PR pharmDx is indicated as an aid in identifying patients eligible for treatment with antihormonal or aromatase inhibitor therapies, as well as an aid in the prognosis and management of breast cancer.
The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is intended for laboratory use as a semi-quantitative detection of progesterone receptor by light microscopy in routinely processed normal and pathological human paraffinembedded tissue. This antibody is indicated for use as an aid in the management, prognosis and prediction of outcome of breast cancer. The clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified individual
Substantial Equivalence:
The DakoCytomation anti-estrogen receptor reagent cocktail. clones 1D5 and ER-2-123. is substantially equivalent to the Ventana ER clone 6F11 and DakoCytomation monoclonal mouse anti-human ER, clone 1D5 in that these 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 the prognosis of breast carcinoma. The difference in visualization does not introduce new issues of safety and effectiveness.
The DakoCytomation PgR 1294 antibody is substantially equivalent to the DakoCytomation PgR 636 antibody, in that these products both bind to progesterone receptor proteins located in the nuclei of breast cancer cells, and use similar detection chemistry principles for visualization.
Performance Characteristics:
Performance characteristics evaluated in support of the ER/PR pharmDx™ IHC kit and components include results on specificity, sensitivity, reproducibility, and concordance testing. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate devices listed above. Further, concordance testing between the DakoCytomation ER/PR pharmDx kit and the reference, Allred method, demonstrated
2
substantially equivalent staining results (99% concordance).
Therefore, based on the information provided in this premarket notification, DakoCytomation concludes that the devices listed above are safe, effective and substantially equivalent to their respective predicate devices in their indications for use, device design, materials, operational principles, and intended use.
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.
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 eagle with three lines forming its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
FEB 1 5 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Tiffany D. Almeroth, RAC Senior, Regulatory Affairs Specialist DakoCytomation California, Inc. 6392 Via Real Carpinteria, California 93013
K042884 Re:
Trade/Device Name: DakoCytomation ER/PR pharmDxTM Kit Regulation Number: 21 CFR § 864.1860 Regulation Name: Immunohistochemistry Reagents and Kits Regulatory Class: II Product Code: MYA, MXZ Dated: January 3, 2005 Received: January 6, 2005
Dear Ms. Almeroth:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, rr you stions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PH. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): __K042884
Monoclonal Mouse Anti-Human Progesterone Receptor, Clone: Device Name: PgR 1294 (DakoCytomation Code No. M3568)
Indications For Use:
The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is intended for laboratory use as a semi-quantitative detection of progesterone receptor by light microscopy in routinely processed normal and or progotical human paraffin-embedded tissue. This antibody is indicated for use as an aid in the management, prognosis and prediction of outcome of breast cancer. The clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified individual.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Per 21 CFR 801.110 | ||
| IVD Use | |||
| (Per 21 CFR 801.119 | (Optional Format 1-2-96) |
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K042884 |
|---|---|
| -------- | --------- |
6
510(k) Number (if known):__K042884
DakoCytomation ER/PR pharmDx™ Device Name: (DakoCytomation Code No. K1903)
Indications For Use:
The DakoCytomation ER/PR pharmDx™ assay is a semi-quantitative immunohistochemical (IHC) kit system to identify estrogen receptor (ER) and progesterone receptor (PR) expression in normal and neoplastic tissues routinely processed and paraffin-embedded for histological evaluation. ER/PR pharmDx specifically detects the ER alpha protein as well as the PR protein located in the cell nucleus of ER and PR-expressing cells respectively.
ER/PR pharmDx is indicated as an aid in identifying patients eligible for treatment with anti-hormonal or aromatase inhibitor therapies, as well as an aid in the prognosis and management of breast cancer.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ (Per 21 CFR 801.109) | OR | Over-The-Counter Use | (Per 21 CFR 801.110) |
|---|---|---|---|---|
| IVD Use | (Per 21 CFR 801.119 |
Division Sign-Off
(Optional Format 1-2-96)
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K042884 |
|---|---|
| -------- | --------- |