(56 days)
PMA # P900013
Not Found
No
The device description and performance studies focus on a monoclonal antibody used for immunohistochemistry, a laboratory technique. There is no mention of computational analysis, image processing, or any terms related to AI/ML.
No.
This device is an in-vitro diagnostic (IVD) used to detect human progesterone receptor in breast cancer tissue to aid in patient selection for hormonal therapy and prognosis, not to treat a condition.
Yes
The intended use explicitly states, "The assay is intended for use as an aid in selecting patients most likely to benefit from hormonal therapy as well as an aid in the prognosis and management of breast cancer," which describes a diagnostic purpose.
No
The device description clearly indicates that the device is a monoclonal antibody, which is a biological reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of human progesterone receptor in tissue sections of human breast cancer by immunohistochemistry." This is a test performed in vitro (outside the body) on a biological sample (tissue sections) to provide information about a patient's health status.
- Aid in Diagnosis/Management: The intended use also states it's "intended for use as an aid in selecting patients most likely to benefit from hormonal therapy as well as an aid in the prognosis and management of breast cancer." This clearly indicates its role in clinical decision-making based on the test results.
- Device Description: The device is a reagent (antibody) used in a laboratory procedure (immunohistochemistry) to detect a specific marker in a biological sample.
- Performance Studies: The document describes performance studies comparing the device to a predicate device (Abbott PR-EIA), which is a common requirement for IVDs.
- Predicate Device: The mention of a predicate device (Abbott PR-EIA) with a PMA number (P900013) further confirms that this type of device is regulated as an IVD.
All 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
Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 is used in the qualitative detection of human progesterone receptor in tissue sections of human breast cancer by immunohistochemistry using a manual or automated procedure. This antibody is indicated for use as an aid in selecting patients most likely to benefit from hormonal therapy as well as an aid in the prognosis and management of breast cancer.
Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 is intended for use in the qualititative detection of human progesterone receptor in tissue sections of human breast cancer by immunohistochemistry. The assay is intended for use as an aid in selecting patients most likely to benefit from hormonal therapy as well as an aid in the prognosis and management of breast cancer.
Product codes (comma separated list FDA assigned to the subject device)
MXZ
Device Description
-
Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, (Product Code No. M3569) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant. The antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, containing fetal bovine serum and 15mM sodium azide. (0.2 mL and 1 mL total volume).
-
Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use Antibody (Product Code No. N1630) consists of a mouse anti-human monoclonal antibody produced as a tissue culture supernatant and pre-diluted in 0.05M Tris-HCl buffer, pH 7.6, containing fetal bovine serum and 15mM sodium azide (7mL and 11 mL sizes).
-
Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use Antibody (Product Code No. NP008) consists of a mouse anti-human monoclonal antibody produced as a tissue culture supernatant and pre-diluted in 0.05M Tris-HCl buffer, pH 7.6, containing fetal bovine serum and 15mM sodium azide (7mL total volume).
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
Not Found
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)
Comparison testing to Abbott PR-EIA:
A comparison study of breast carcinomas was performed to demonstrate substantial equivalence to the Abbott PR-EIA.
Sample size: 106 tests were performed on 101 specimens. 97 specimens had corresponding PR-EIA results and were used for concordance calculation.
Key Results:
Concordance = 88 / 97 = 90.7%.
Using the PR-EIA as the predicate device, sensitivity was determined to be 41/47 = 87.2%
Specificity was determined to be 47/50 = 94%.
The Kappa statistic indicated a 0.8139 kappa, which corresponds to an almost perfect correlation for the qualitative assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 87.2%
Specificity: 94%
Kappa: 0.8139
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.
Abbott PR-EIA approved by the FDA as PMA # P900013 and downclassified to Class II by 21 CFR 864.1860, Immunohistochemistry Reagents and Kits on June 3, 1998.
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
| 510(k) Summary | DAKO Mouse Anti-Human
Progesterone Receptor
Clone PgR 636 | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter: | K020023
DAKO Corporation
6392 Via Real
Carpinteria, CA 93013
805-566-6655 | FEB 2 8 2002 |
| Contact: | Gretchen M. Murray, Ph.D., Regulatory and Clinical Affairs Manager | |
| Date Summary
Prepared: | December 18, 2001 | |
| Device Name: | 1) DAKO® Monoclonal Mouse Anti-Human Progesterone Receptor, Clone
PgR 636, Antibody for Immunoenzymatic Staining (Product Code No.
M3569)
2) DAKO® Monoclonal Mouse Anti-Human Progesterone Receptor, Clone
PgR 636, Ready-to-Use Antibody for Immunoenzymatic Staining (Product
Code No. N1630)
3) DAKO® Monoclonal Mouse Anti-Human Progesterone Receptor, Clone
PgR 636, Ready-to-Use Antibody for Immunoenzymatic Staining (Product
Code No. NP008) | |
| 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 Device: | Abbott PR-EIA approved by the FDA as PMA # P900013 and
downclassified to Class II by 21 CFR 864.1860, Immunohistochemistry
Reagents and Kits on June 3, 1998. Device package insert from this
product is included in Section 2 of this submission. | |
| Device
Description: | 1) Monoclonal Mouse Anti-Human Progesterone Receptor,
Clone PgR 636, (Product Code No. M3569) is a mouse anti-human
monoclonal antibody produced as a tissue culture supernatant. The
antibody is supplied in 0.05M Tris-HCl buffer, pH 7.2, containing fetal
bovine serum and 15mM sodium azide. (0.2 mL and 1 mL total volume).
- Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636,
Ready-to-Use Antibody (Product Code No. N1630) consists of a mouse
anti-human monoclonal antibody produced as a tissue culture | |
1
:
1
| 510(k) Summary | | DAKO Mouse Anti-Human
Progesterone Receptor
Clone PgR 636 | | 14 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| supernatant and pre-diluted in 0.05M Tris-HCl buffer, pH 7.6, containing
fetal bovine serum and 15mM sodium azide (7mL and 11 mL sizes). | | | | |
| 3) Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636,
Ready-to-Use Antibody (Product Code No. NP008) consists of a mouse
anti-human monoclonal antibody produced as a tissue culture
supernatant and pre-diluted in 0.05M Tris-HCl buffer, pH 7.6, containing
fetal bovine serum and 15mM sodium azide (7mL total volume). | | | | |
| Intended Use: | | For In Vitro Diagnostic Use | | |
| | | Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 is
used in the qualitative detection of human progesterone receptor in
tissue sections of human breast cancer by immunohistochemistry using a
manual or automated procedure. This antibody is indicated for use as an
aid in selecting patients most likely to benefit from hormonal therapy as
well as an aid in the prognosis and management of breast cancer. | | |
| Experimental
Data: | | | Distribution of PgR throughout normal tissue has been reported in a
variety of studies. The nuclei of uterine gland cells were found to be
strongly immunoreactive. Weaker immunostaining was observed in the
nuclei of endometrial and prostatic stromal cells. | |
| | | Immunoreactivity in a panel of normal tissues: | | |
| | | The required panel of normal tissues was tested with this antibody as
specified in the 6/3/98 final version of Guidance for Submissions of
Immunohistochemistry Applications to the FDA. All tissues were formalin
fixed and paraffin embedded. Staining was performed using the DAKO
LSAB®2 Peroxidase kit system (Code No. K0672). | | |
| | | Table 1 contains a list of positive tissues with PgR immunoreactivity. All
tissues were formalin-fixed and paraffin embedded and stained with Anti-
PgR, 636 according to the instructions in the package insert. | | |
and the commend of the comments of
2
| TABLE 1: Summary of PgR Normal Tissue Reactivity | |
|---|---|
| TISSUE TYPE | |
| (# tested) | POSITIVE TISSUE ELEMENT |
| STAINING AND STAINING PATTERN | |
| Breast (3) | Ductal epithelial cells (3+ staining intensity, 3/3 tissues) |
| Cervix uteri (3) | Glandular epithelial cells (2+ staining intensity, 1/3 tissues); Stromal fibroblasts(2+ staining intensity, 2/3 tissues) |
| Pituitary (3) | Pituicytes (2+ staining intensity, 1/3 tissues) |
| Prostate (3) | Stromal fibroblasts (2+ staining intensity, 1/3 tissues) |
| Uterus (3) | Endometrial stroma (2+ staining intensity 3/3 tissues) |
| Myometrium (2+ staining intensity, 3/3 tissues) | |
| Endometrial glands (2+ staining intensity, 2/3 tissues) |
Negative tissues included adrenal (4), bone marrow (2,) brain/cerebellum (4), brain/cerebrum (3), colon (3), esophagus (3), heart (3), kidney (3), liver (3), lung (3), mesothelial cells (3), ovary (3), pancreas (3), parathyroid (3), peripheral nerve (3), salivary gland (3), skeletal muscle (3), skin (3), small intestine (3), spleen (4), stomach (3), testis (3), thymus (3), thyroid (3), and tonsil (3).
A second survey of normal tissues demonstrated positivity in endometrium and weak positivity in prostate after heat-induced epitope retrieval. Negative tissues included esophagus, testes, breast liver, kidney, skeletal muscle, placenta, adrenal, tonsil, lung, colon, skin, pancreas, spleen, thyroid, stomach and cardiac muscle. (See Press article)
Other testing with PgR 636 clone
Western blot
PgR 636 was tested in Western blots using whole cell extracts from 2 cell lines, MDA-MB-231 (PR negative) and T47D (PR A and PR B positive). PgR 636 reacted strongly with both PR-A and PR-B bands from T47D cells, and gave little or no cross reactivity with other proteins in the T47D cell extracts. PgR 636 reacted equally with unliganded and liganded PR. The domain mapping experiments demonstrated that PgR 636 reacted with amino terminal domain (AN) and the amino terminal domain linked to DBD, but not with any of the C-terminal tail (aa 919-933) of human PR. Thus, the PgR 636 epitope is contained within the amino termal domain common to the A and B receptors in a region between an 165 and 533. (See Press article)
Immunohistochemistry of tumors
PR 636 was used to immunostain a variety of 60 different tumor types. Breast cancer (5/11), uterine (2/2), ovarian (2/6), and endometrial (2/2) carcinomas stained strongly. Medullary carcinoma of the thyroid (1/2) and testicular yolk sac tumor were positive. Other tumors including
3
143
melanoma, lymphoma and neuroendocrine and neural turnors were negative for PR expression. (See Press article)
Comparison testing to Abbott PR-EIA
Substantial equivalence to the Abbott PR-EIA was demonstrated in a comparison study of breast carcinomas. One hundred six tests were performed on 101 specimens previously evaluated for PR presence using the Abbott PR-EIA. Two specimens had too little tumor tissue for evaluation. Two specimens had no corresponding PR-EIA results for the 97 specimens indicated 53 as negative for PR by IHC, and 44 positive. Correlation with the PR-EIA is presented in Table 2.
Concordance of DAKO Monoclonal Mouse anti-human Progesterone Table2:
| Abbott Result | |||
|---|---|---|---|
| DAKO Result | Negative | Positive | Total |
| Negative | 47 | 6 | 53 |
| Positive | 3 | 41 | 44 |
| Total | 50 | 47 | 97 |
Receptor clone PgR 636 with Abbott PR-EIA
Concordance calculation showed concordance = 88 / 97 = 90.7% in this trial. Using the PR-ElA as the predicate device, sensitivity was determined to be 41/47 = 87.2% while specificity was determined to be 47/50, = 94%. The Kappa statistic indicated a 0.8139 kappa, which corresponds to an almost perfect correlation for the qualitative assessment.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wings, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Gretchen M. Murray, Ph.D. Regulatory and Clinical Affairs Manager DAKO Corporation 6392 Via Real Carpinteria, California 93013
FEB 2 8 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 8 2002
Re: K020023
Trade/Device Name: DAKO Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 Antibody for Immunoenzymatic Staining available in three different iterations:
-
- (Product Code No. M3569),
-
- Ready-to-use (Product Code No. N1630),
-
- Ready-to-use (Product Code No. NP008)
Regulation Number: 21 CFR § 864.1860 Regulation Name: Immunohistochemistry Reagents and Kits Regulatory Class: II Product Code: MXZ Dated: December 31, 2001 Received: January 3, 2002
Dear Dr. Murray:
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 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); good manufacturing practice requirements as set 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.
5
Page 2
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 Antibody for Immunoenzymatic Staining available in three different iterations:
- DAKO Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Antibody for Immunoenzymatic Staining (Product Code No. M3569)
-
DAKO® Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use Antibody for Immunoenzymatic Staining (Product Code No. N1630)
-
DAKO® Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use Antibody for Immunoenzymatic Staining (Product Code No. NP008)
Indications For Use:
Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636 is intended for use in the qualititative detection of human progesterone receptor in tissue sections of human breast cancer by immunohistochemistry. The assay is intended for use as an aid in selecting patients most likely to benefit from hormonal therapy as well as an aid in the prognosis and management 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 having knowledge of all the potential antibody reactivities.
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)
IVD Use (Per 21 CFR 801.119) OR
Over-The-Counter Use (Per 21 CFR 801.110
Sousan S. Altaie
(Division Sign-Off) Division of Clinical Laboratory Devices Division of Chilegi __________________________________________________________________________________________________________________________________________________________