(242 days)
P950011
P950011
No
The device description and performance studies describe a standard radioimmunoassay (RIA) based on antibody binding and radioactivity measurement, with no mention of AI or ML techniques.
No
This device is an in vitro diagnostic (IVD) test used to detect an antigen in serum and plasma, which aids in the early detection of recurrence in breast cancer patients. It does not directly treat or provide therapy to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro test for the quantitative determination of DF3 antibodydefined antigen..." and that "Serial test results obtained with the Centocor CA 15-3 RIA, are useful in the early detection of recurrence in patients previously treated for stage III breast cancer...". This indicates its use in identifying a medical condition (recurrence of cancer), which is a diagnostic purpose. Additionally, the "Device Description" section states it is "an in vitro diagnostic device".
No
The device description clearly outlines a physical kit containing reagents, beads, and radio-labeled antibodies, which are hardware components used in a laboratory setting for an in vitro diagnostic test.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Centocor CA 15-3 RIA is an in vitro test for the quantitative determination of DF3 antibodydefined antigen...".
The "Device Description" section also begins by stating: "The Centocor CA 15-3 RIA is an in vitro diagnostic device based on the well established RIA 'forward sandwich' principle."
These statements clearly indicate that the device is intended for use outside of the body to examine specimens for diagnostic purposes, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Centocor CA 15-3 RIA is an in vitro test for the quantitative determination of DF3 antibody-defined antigen, encoded by the MUC 1 gene, in serum and plasma, Serial test results obtained with the Centocor CA 15-3 RIA, are useful in the early detection of recurrence in patients previously treated for stage III breast cancer, who are clinically free of disease. Early detection of recurrence cannot be readily accomplished by routine clinical or diagnostic studies alone. The use of a circulating serum tumor marker assay, such as Centocor CA 15-3 RIA, can be useful in the identification of these patients. The Centocor CA 15-3 RIA should be used in conjunction with all relevant information derived from diagnostic tests, physical examination and full medical history, in accordance with appropriate patient management procedures
Product codes
MOI
Device Description
The Centocor CA 15-3 RIA is an in vitro diagnostic device based on the well established RIA "forward sandwich" principle. The device is in kit format and consists of murine monoclonal antibody 115D8-coated polystyrene beads, standards, diluent, positive control, and 122 radio-labeled, murine monoclonal antibody, DF3. Antibody coated beads are incubated with a specimen or the appropriate standards and controls. During this initial incubation step, DF3 antibody-defined antigen present in the specimen are bound by the coated beads. Unbound material present in the specimen are removed by aspiration and washing. In the second step, the beads are incubated with DF3 radio-labeled with "2". The tracer detects DF3 antibody-defined antigen bound to the beads during the initial incubation step. The unbound tracer antibody is removed by washing and aspiration. The bound radioactivity is determined by counting the beads in a gamma counter. The bound radioactivity is directly proportional to the concentration of the DF3 antibody-defined antigen in the specimen. A standard curve is obtained by plotting the DF3 antibody-defined antigen concentration of the standards against the bound radioactivity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Analytical performance of the CA 15-3 assay was evaluated in a study in which serum samples were obtained from 204 breast cancer patients. Each sample was analyzed using the Centocor CA 15-3 RIA and the TRUQUANT BR method. Samples were analyzed on two occasions, with both assays, using multiple product lots. The assays were compared for linear agreement using Bablock-Passing regression analysis, with the other commercial method as the reference method.
Results:
204 = Total samples tested
0.93 = Slope
-2.04 = Intercept
0.92 = Spearman's Rank Correlation
Inter and Intra Assay Precision: Twenty-four coded samples (2 sets of twelve samples) and one kit control were tested in duplicate by six laboratories using three Centocor CA 15-3 RIA kit lots on each of three days. The order of the coded samples was randomized for each day's testing. The estimates of intra-assay precision (CV ) ranged from 5.4 to 9.4%. The estimates of inter-assay lot precision (CV .) ranged from 7.0% to 11.5%. Samples with a mean CA 15-3 assay value around the reference value of 35 U/mL had CV, s of in the range of 5.8% to 8.5%.
Conclusion from Studies: The Centocor CA 15-3 RIA and the TRUQUANT BR RIA demonstrated good linear agreement and precision comparable to that claimed in the TRUQUANT BR RIA product instructions. The two products are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P950011
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
0
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K963803". The characters are written in a dark color, possibly black or dark gray, against a white background. The handwriting appears somewhat rough or stylized, with varying line thickness and slight imperfections, giving it a distinct, non-uniform appearance.
Image /page/0/Picture/2 description: The image shows the word "Centocor" in a bold, sans-serif font. To the left of the word is a stylized, circular logo. The logo is black with a white crescent shape cut out of the right side. The text and logo are all in black against a white background.
MAY 2 3 1997
510(K) SUMMARY CENTOCOR® CA 15-3TM RIA 10.0
Submitter Information
- Centocor Incorporated Address: 200 Great Valley Parkway Malvern, PA 19355
For information regarding this 510(k) Summary please contact, Centocor, Inc., Mr. Christopher D. Zalesky, (610) 651-6815
Summary Preparation Date: September 20, 1996
Name of the Device:
| Trade/Proprietary Name: | Centocor CA 15-3TM RIA |
|---|---|
| Common/Usual Name: | Radioimmunoassay for the quantitative determination of |
| DF3-defined antigen in serum or plasma | |
| Classification Name: | In accordance with FDA's reclassification order issued |
| September 19, 1996, Docket # 95P-0136, Serum Tumor | |
| Markers, Centocor CA 15-3 RIA has been classified as a | |
| Class II device, Tumor Associated Antigen Immunoassay | |
| Systems. |
1
Substantial Equivalence
The Centocor CA 15-3 RIA has been found to be substantially equivalent to Biomira Diagnostic's TRUQUANT BR RIA, P950011, approved by the Food and Drug Administration on March 29, 1996.
Device Description:
The Centocor CA 15-3 RIA is an in vitro diagnostic device based on the well established RIA "forward sandwich" principle. The device is in kit format and consists of murine monoclonal antibody 115D8-coated polystyrene beads, standards, diluent, positive control, and 122 radio-labeled, murine monoclonal antibody, DF3. Antibody coated beads are incubated with a specimen or the appropriate standards and controls. During this initial incubation step, DF3 antibody-defined antigen present in the specimen are bound by the coated beads. Unbound material present in the specimen are removed by aspiration and washing. In the second step, the beads are incubated with DF3 radio-labeled with "2". The tracer detects DF3 antibody-defined antigen bound to the beads during the initial incubation step. The unbound tracer antibody is removed by washing and aspiration. The bound radioactivity is determined by counting the beads in a gamma counter. The bound radioactivity is directly proportional to the concentration of the DF3 antibody-defined antigen in the specimen. A standard curve is obtained by plotting the DF3 antibody-defined antigen concentration of the standards against the bound radioactivity.
Intended Use
The Centocor CA 15-3 RIA is an in vitro test for the quantitative determination of DF3 antibody-defined antigen, encoded by the MUC 1 gene, in serum and plasma of patients previously treated for stage II or stage III breast cancer. Serial test results obtained with the Centocor CA 15-3 RIA, in patients who are clinically free of disease,
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should be used in conjunction with all relevant information derived from diagnostic tests, physical examination, and full medical history in accordance with appropriate patient management procedures used for early detection of recurrence.
Breast cancer is the most common malignancy among woman in the United States. It is estimated that approximately 184,000 new cases of breast cancer will be diagnosed each year and that approximately 44.000 woman will die of the disease. One of every nine woman in the U.S. will develop breast cancer and approximately 30% of woman who have this malignancy will die of the disease. Metastatic disease may be present at the time of initial diagnosis and can occur at any time following primary therapy. Up to 70% of patients with metastases will respond to systemic treatment with cytotoxic drugs or endocrine therapy; therefore, early detection of recurrence is important to patient management. The median survival following diagnosis of recurrent disease is approximately 2 years, but may range from a few months to decades.
In patients previously treated for stage II or stage III disease, early detection of recurrence cannot be readily accomplished by routine clinical or diagnostic studies alone. A circulating serum tumor marker assay, such as the Centocor CA 15-3 RIA, can be useful in the identification of these patients.
Technological Characteristics:
The Centocor CA 15-3 RIA and TRUQUANT BR RIA both utilize well established solid phase radioimmunoassay procedures for quantifying the amount of antigen in patient specimens. The Centocor CA 15-3 RIA is based on the "forward sandwich" principle. The amount of tracer bound to the assay solid phase is directly proportional to the amount of antigen present in the patient sample. The TRUQUANT BR RIA is based on the "competitive inhibition" principle. With this method, the amount of tracer bound to the solid phase is inversely proportional to the amount of antigen present in the patient sample.
3
Both the Centocor CA 15-3 RIA and the TRUQUANT BR RIA utilize monoclonal antibodies directed against mucinous antigens associated with carcinoma of the breast. These antigens are large molecular weight glycoproteins with O-linked oligosaccharide chains. Breast carcinoma-associated antigen, encoded by the human MUC 1 gene, is identified by several names including DF3 antibody-defined antigen, MAM 6 and milk mucin.
Performance Data
Analytical Performance in Breast Cancer Patients
Analytical performance of the CA 15-3 assay was evaluated in a study in which serum samples were obtained from 204 breast cancer patients. Each sample was analyzed using the Centocor CA 15-3 RIA and the TRUQUANT BR method. Samples were analyzed on two occasions, with both assays, using multiple product lots. The assays were compared for linear agreement using Bablock-Passing regression analysis, with the other commercial method as the reference method. The results are summarized below:
204 = Total samples tested 0.93 = Slope -2.04 = Intercept 0.92 = Spearman's Rank Correlation
Inter and Intra Assay Precision
Twenty-four coded samples (2 sets of twelve samples) and one kit control were tested in duplicate by six laboratories using three Centocor CA 15-3 RIA kit lots on each of three days. The order of the coded samples was randomized for each day's testing. The estimates of intra-assay precision (CV ) ranged from 5.4 to 9.4%. The estimates of inter-assay lot precision (CV .) ranged from 7.0% to 11.5%. Samples with a mean CA 15-3
4
assay value around the reference value of 35 U/mL had CV, s of in the range of 5.8% to 8.5%. Nonclinical Studies
Conclusion from Studies
The Centocor CA 15-3 RIA and the TRUQUANT BR RIA demonstrated good linear agreement and precision comparable to that claimed in the TRUQUANT BR RIA product instructions. The two products are substantially equivalent.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 23 1997
Mr. Christopher D. Zalesky Director, Regulatory Affairs Centocor Incorporated 200 Great Valley Parkway --Malvern, Pennsylvania 19355
Re: K963803/S2 Trade Name: Centocor CA 15-3TM RIA Regulatory Class: II Product Code: MOI Dated: May 7, 1997 Received: May 8, 1997
Dear Mr. Zalesky:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
6
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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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
7
Page 1 of 1
510(k) Number (if known): K963803
Device Name: Centocor ®CA 15-3TM RIA
INDICATIONS FOR USE
The Centocor CA 15-3 RIA is an in vitro test for the quantitative determination of DF3 antibodydefined antigen, encoded by the MUC 1 gene, in serum and plasma,
Serial test results obtained with the Centocor CA 15-3 RIA, are useful in the early detection of recurrence in patients previously treated for stage III breast cancer, who are clinically free of disease. Early detection of recurrence cannot be readily accomplished by routine clinical or diagnostic studies alone. The use of a circulating serum tumor marker assay, such as Centocor CA 15-3 RIA, can be useful in the identification of these patients. The Centocor CA 15-3 RIA should be used in conjunction with all relevant information derived from diagnostic tests, physical examination and full medical history, in accordance with appropriate patient management procedures
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
Gata E. Macini
(Division Sian-Off) Division of Clinical Laboratory Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use
(Optional Format 1-2-96)
INDICAT.WPD