(366 days)
Not Found
No
The 510(k) summary describes a standard immunohistochemistry (IHC) assay kit for detecting estrogen receptors. There is no mention of image processing, AI, ML, or any computational analysis beyond the pathologist's visual interpretation. The performance studies focus on analytical characteristics of the assay itself, not on the performance of an AI/ML algorithm.
No.
This device is an in vitro diagnostic (IVD) tool used for the semi-quantitative detection of human estrogen receptor in tissue sections, aiding in assessing the likelihood of response to therapy and prognosis, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." and describes its use in assessing the likelihood of response to therapy, prognosis, and management of breast cancer patients, all of which are diagnostic activities.
No
The device is an immunohistochemical (IHC) kit assay, which involves physical reagents (antibodies) and laboratory procedures, not solely 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 Assay: The device is a kit assay used to detect a specific marker (Estrogen Receptor a) in tissue samples (formalin-fixed, paraffin-embedded tissue sections). This is a classic example of an in vitro diagnostic test, as it is performed outside of the living body on biological specimens to provide information for diagnosis, prognosis, or management.
- Clinical Context: The intended use describes how the information gained from the assay can aid in assessing the likelihood of response to therapy, prognosis, and management of breast cancer patients. This clearly indicates a diagnostic purpose.
- Intended User: The intended user is a "qualified pathologist," who is a medical professional responsible for interpreting diagnostic tests.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use.
Monoclonal Rabbit Anti-Human Estrogen Receptor a (ER a) antibody, Clone SP1, may be used in the semi-quantitative detection of human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer by immunohistochemistry. The information gained by this assay can aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.
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 pahtologist.
Product codes (comma separated list FDA assigned to the subject device)
MYA
Device Description
Dako Monoclonal Rabbit Anti-Human Estrogen Receptor a antibody, Clone SP1 is a semiquantitative immunohistochemical (IHC) kit assay to identify estrogen receptor (ER) expression in normal and neoplastic tissues routinely processed and paraffin-embedded.
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 pahtologist
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 for the Estrogen Receptor Clone SP1 IHC assay include results on analytical specificity and sensitivity, precision, reproducibility and method comparison testing. Results of all testing conducted substantial equivalence to the predicate device listed above.
Based on the information provided in this premarket notification, Dako concludes that Monoclonal Rabbit Anti-Estrogen Receptor a, Clone SP1 is substantially equivalent to the predicate device and is safe and effective for its intended use.
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.
0
MAY - 8 2009
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92 (c).
The assigned 510(k) number is: K081286
| Submitter: | Dako North America, Inc.
6392 Via Real
Carpinteria, CA 93013
PH. 805.566.6655 FX. 805.566.0866
Establishment registration number: 2022180 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly Miller
Manager, Regulatory Affairs
PH. 805.566.6655 ext. 5330
Fax: 805.566.0866 |
| Date Summary Prepared: | April 8, 2009 |
| Device Name(s): | Monoclonal Rabbit Anti-Human Estrogen Receptor a antibody,
Clone SP1
(Code M3634) |
| Device Classification: | Class II (21 CFR 864.1860) |
| Predicate Device: | Monoclonal Mouse ER 1D5/ER-2-123 in the Dako ER/PR
pharmDx™ Kit (K042884) |
Device Description:
Dako Monoclonal Rabbit Anti-Human Estrogen Receptor a antibody, Clone SP1 is a semiquantitative immunohistochemical (IHC) kit assay to identify estrogen receptor (ER) expression in normal and neoplastic tissues routinely processed and paraffin-embedded.
Intended Use:
For in vitro diagnostic use.
Monoclonal Rabbit Anti-Human Estrogen Receptor a (ER a) antibody, Clone SP1, may be used in the semi-quantitative detection of human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer by immunohistochemistry. The information gained by this assay can aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.
Clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made
1
within the context of the patient's clinical history and other diagnostic tests by a qualified pahtologist.
Substantial Equivalence:
Dako Estrogen Receptor Clone SP1 immunohistochemical assay is substantially equivalent to Monoclonal Mouse ER 1D5/ER-2-123 in 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 the prognosis of breast carcinoma.
Performance Characteristics:
Performance characteristics evaluated for the Estrogen Receptor Clone SP1 IHC assay include results on analytical specificity and sensitivity, precision, reproducibility and method comparison testing. Results of all testing conducted substantial equivalence to the predicate device listed above.
Based on the information provided in this premarket notification, Dako concludes that Monoclonal Rabbit Anti-Estrogen Receptor a, Clone SP1 is substantially equivalent to the predicate device and is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 2098 Gailher Road Rockville MD 20850
MAY - 8 2009
Dako North America, Inc. c/o Kelly Miller Manager RA 6392 Via Real Carpinteria, CA 93013
Re: K081286
Trade/Device Name: Dako Monoclonal Rabbit Anti-Human Estrogen Receptor, Clone SP1 Regulation Number: 21 CFR 864.1860 Regulation Name: Immunohistochemistry reagents and kits Regulatory Class: Class II Product Code: MYA Dated: May 4, 2009 Received: May 5, 2009
Dear Ms. Miller:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
3
Page 2 - Ms. Kelly Miller
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mana M. Chan
Maria Chan, PhD Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K081286
Device Name: Dako Monoclonal Rabbit Estrogen Receptor a, Clone SP1
Indications For Use:
For in vitro diagnostic use.
Monoclonal Rabbit Anti-Human Estrogen Receptor a (ER a) antibody, Clone SP1, may be used in the semi-quantitative detection of human estrogen receptor in formalin-fixed, paraffin-embedded tissue sections of human breast cancer by immunohistochemistry. The information gained by this assay can aid in assessing the likelihood of response to therapy as well as in the prognosis and management of breast cancer patients.
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 pathologist.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use J (Per 21 CFR 801.109)
OR
Maris M Chan
Division Sign-Off
Over-The-Counter Use (Per 21 CFR 801.110)
IVD Use_______________________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.119) Office of in Vitro Dlagnostic Device Evaluation and Safety
Proprietary and confidential
8-Apr-09
510kl
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