(312 days)
Not Found
Not Found
No
The device description details a competitive inhibition radioimmunoassay (RIA) method, which is a traditional laboratory technique. There is no mention of AI, ML, or any computational methods that would suggest their use in the device's operation or data analysis. The performance studies describe statistical analysis (Cox regression) of the assay results, not the use of AI/ML for interpretation or prediction.
No
The device is an in vitro diagnostic device used to measure a biomarker (CA 27.29 antigen) for monitoring breast cancer, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic device."
No
The device description clearly outlines a competitive inhibition RIA method involving physical components like iodine-labelled monoclonal antibodies, antigen-coated polystyrene tubes, and the measurement of bound radioactivity. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "TRUQUANT® BR™ RIA is an in vitro diagnostic device indicated for the quantitative determination of CA 27.29 antigen in serum or EDTA plasma..."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TRUQUANT® BR™ RIA is an in vitro diagnostic device indicated for the quantitative determination of CA 27.29 antigen in serum or EDTA plasma of patients previously treated for stage II or stage III breast cancer. Serial testing for CA 27.29 antigen with TRUQUANT® BR™ RIA in patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of recurrence. In addition, quantitation of CA 27.29 antigen in conjunction with other clinical methods can be used as an aid in monitoring response to therapy in patients with stage IV breast cancer.
Product codes (comma separated list FDA assigned to the subject device)
MOI
Device Description
TRUQUANT® BR™ RIA quantitates CA 27.29 by competitive inhibition RIA. 12ª(odinelabelled monoclonal antibody, specific for CA 27.29, is added to antigen-coated polystyrene tubes with the specimen in the form of plasma or serum. Antigen (CA 27.29) in the specimen inhibits the antibody from binding to the CA 27.29 antigen on the tube and after a subsequent wash step, bound radioactivity is determined. A calibration curve, generated from standards containing known quantities of CA 27.29, is used to determine the amount of antigen in the specimen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
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)
The clinical studies support the safety and effectiveness of TRUQUANT® BR™ RIA for monitoring remission and progression in breast cancer patients with stage IV disease. Cox regression analysis of the prospective study data indicates that a 50% or greater increase or decrease in CA27.29 values from baseline, detected at least one examination prior to clinical assessment of status change, is a statistically significant predictor of disease progression or remission, respectively. The operating characteristics of the assay in the mucin-producing subset of patients (baseline marker levels above the upper limit of normal, 37.7 U/mL) provide evidence for the utility of TRUQUANT® BR™ RIA in determining response to therapy in patients with metastatic breast cancer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
TRUQUANT® BR™ RIA exhibited a sensitivity of 25% (5/20) and specificity of 87% (54/62), for an accuracy of 72% (59/82), in predicting disease remission in patients with progressive or stable disease. In patients with complete or partial remission or with stable disease, TRUQUANT® BR™ RIA demonstrated a sensitivity of 52% (17/33), a specificity of 59% (10/17) and accuracy of 54% (27/50) in detecting disease progression. Furthermore, the positive and negative predictive values of 71% (17/24) and 78% (54/69) for disease progression and remission, respectively, provide clinically useful information in the management of late stage breast cancer. A marker increase of 50% or more suggests a high probability of treatment failure and likelihood of disease progression; a marker decrease of less than 50% is also associated with ineffective therapy and failure to induce remission.
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.
TRUQUANT® BR™ RIA
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
§ 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.
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KQ65141
OCT 31 1997
BIOMIRA Diagnostics Inc. 30 Meridian Road Rexdale, Ontario M9W 4Z7 Canada
ITEM 1.0 510(k) SUMMARY TRUQUANT® BR™ RIA
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safety Medical Devices Act of 1990.
Submitter :
| BIOMIRA Diagnostics Inc.
30 Meridian Road
Rexdale, Ontario, Canada
| M9W 4Z7 | |
|---|---|
| Telephone: (416) 674-0863 | |
| Facsimile: (416) 674-2992 | |
| Official Contact: | Bo Hollas |
| Manager QA/Regulatory | |
| BIOMIRA Diagnostics Inc. | |
| Designated Alternate: | Marilyn Olson |
| Director, Regulatory Affairs | |
| BIOMIRA Inc. | |
| Edmonton Research Park | |
| 2011-94 Street | |
| Edmonton, Alberta | |
| Canada T6N 1H1 | |
| Telephone: (403) 450-3761 | |
| Facsimile: (403) 463-0871 | |
| Authorized US Representative: | Jillian Castrucci |
| Manager, Regulatory Affairs | |
| BIOMIRA USA Corp. | |
| 1002 East Park Blvd. | |
| Cranberry, New Jersey | |
| 08512 | |
| Telephone: (609) 655-5300 | |
| Facsimile: (609) 655-1755 |
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Date Submitted:
December 20, 1996
Device Name:
Trade Name: TRUQUANT® BR™ RIA
Generic Name: This device does not have an official generic name.
Classificati Class II
Predicate Device: TRUQUANT® BR™ RIA
Device Description:
TRUQUANT® BR™ RIA quantitates CA 27.29 by competitive inhibition RIA. 12ª(odinelabelled monoclonal antibody, specific for CA 27.29, is added to antigen-coated polystyrene tubes with the specimen in the form of plasma or serum. Antigen (CA 27.29) in the specimen inhibits the antibody from binding to the CA 27.29 antigen on the tube and after a subsequent wash step, bound radioactivity is determined. A calibration curve, generated from standards containing known quantities of CA 27.29, is used to determine the amount of antigen in the specimen.
Intended Use:
TRUQUANT® BR™ RIA is an in vitro diagnostic device indicated for the quantitative determination of CA 27.29 antigen in serum or EDTA plasma of patients previously treated for stage II or stage III breast cancer. Serial testing for CA 27.29 antigen with TRUQUANT® BR™ RIA in patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of recurrence. In addition, quantitation of CA 27.29 antigen in conjunction with other clinical methods can be used as an aid in monitoring response to therapy in patients with stage IV breast cancer.
2
Summery and Conclusion
The clinical studies support the safety and effectiveness of TRUQUANT® BR™ RIA for monitoring remission and progression in breast cancer patients with stage IV disease. Cox regression analysis of the prospective study data indicates that a 50% or greater increase or decrease in CA27.29 values from baseline, detected at least one examination prior to clinical assessment of status change, is a statistically significant predictor of disease progression or remission, respectively. The operating characteristics of the assay in the mucin-producing subset of patients (baseline marker levels above the upper limit of normal, 37.7 U/mL) provide evidence for the utility of TRUQUANT® BR™ RIA in determining response to therapy in patients with metastatic breast cancer. TRUQUANT® BR™ RIA exhibited a sensitivity of 25% (5/20) and specificity of 87% (54/62), for an accuracy of 72% (59/82), in predicting disease remission in patients with progressive or stable disease. In patients with complete or partial remission or with stable disease, TRUQUANT® BR™ RIA demonstrated a sensitivity of 52% (17/33), a specificity of 59% (10/17) and accuracy of 54% (27/50) in detecting disease progression. Furthermore, the positive and negative predictive values of 71% (17/24) and 78% (54/69) for disease progression and remission, respectively, provide clinically useful information in the management of late stage breast cancer. A marker increase of 50% or more suggests a high probability of treatment failure and likelihood of disease progression; a marker decrease of less than 50% is also associated with ineffective therapy and failure to induce remission.
In medical practice, the premature withdrawl of effective therapy or prolonged maintenance of ineffective treatment are critical consequences predicated on accurate assessment of patient status. TRUQUANT® BR™ RIA can facilitate important clinical decisions through surveillance of soluble marker levels in metastatic breast cancer patients whose turnors produce and secrete mucin (CA27.29).
Conclusion: TRUQUANT® BR™ RIA, when used in conjunction with other clinical criteria, can assist the clinician in determining response to therapy and in management of breast cancer patients with stage IV disease.
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. . . . . .
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Bo Hollas Manager QA/Regulatory Biomira Diagnostics, Inc. 30 Meridian Road Rexdale, Ontario, CANADA
OCT 31 1997
Re: K965141 TRUQUANT® BR™ RIA Trade Name: Requlatory Class: II Product Code: MOI October 16, 1997 Dated: Received: October 17, 1997
Dear Ms. Hollas:
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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
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Page 2
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.
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 Butman
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
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|---|---|---|
510(k) Number (if known):_ K96514 L___________________________________________________________________________________________________________________________________________
Device Name:_
Indications For Use:
2.3 Intended Use
TRUQUANT® BR™ RIA is an in vitro diagnostic device indicated for the quantitative determination of CA 27.29 antigen in serum or EDTA plasma of patients previously treated for stage II or stage III breast cancer. Serial testing for CA 27.29 antigen with TRUQUANT® BR™ RIA in patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of recurrence. In addition, quantitation of CA 27.29 antigen in conjunction with other clinical methods can be used as an aid in monitoring response to therapy in patients with stage IV breast cancer.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Clinical Laboratory Devices |
| 510(k) Number |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |