(104 days)
No
The description focuses on a standard immunoassay system and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for quantitative measurement of a specific antigen to aid in the management and monitoring of breast cancer patients, rather than directly treating a condition.
Yes
The device is intended for the quantitative measurement of an antigen in serum or plasma to aid in the early detection of recurrence of breast cancer and to monitor progression or response to treatment for metastatic breast cancer, which are diagnostic purposes.
No
The device description clearly outlines a system comprised of reagent packs, calibrators, and instrumentation, indicating a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the VITROS® CA 15-3 is an in vitro assay intended for the quantitative measurement of a specific antigen in serum or plasma from patients. This clearly indicates that the test is performed on samples taken from the human body, outside of the body.
- Device Description: The "Device Description" further supports this by describing the system as using luminescence for the determination of selected analytes in human body fluids, specifically mentioning serum and plasma. It also describes the components as "VITROS Immunodiagnostic Products," which is a common term for IVD components.
- Performance Studies: The "Summary of Performance Studies" describes testing performed with samples from a variety of clinical categories, including apparently healthy individuals, patients with cancer, and patients with non-malignant diseases. This is consistent with the evaluation of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K963803 Centocor CA 15-3 RIA) and "Reference Device(s)" (K962919 VITROS Immunodiagnostic System; K984310 VITROS Immunodiagnostic Products Total T3) with K numbers strongly suggests that this device has gone through a regulatory process for medical devices, and the nature of the predicate and reference devices (other diagnostic systems and assays) further confirms its IVD classification.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The VITROS®CA 15-3 is an in vitro assay intended for the quantitative measurement of DF3 defined antigen in serum or plasma (EDTA or heparin) from patients previously treated for stage II or stage III breast cancer. Serial test results obtained with the VITROS CA 15-3 assay, in patients who are clinically free of disease, should be used in conjunction with all relevant information derived from diagnostic test, physical examination and full medical history in accordance with appropriate patient management procedures used for early detection of recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring progression or response to treatment.
Product codes (comma separated list FDA assigned to the subject device)
MOI
Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
-
- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products CA 15-3 Reagent Pack, VITROS Immunodiagnostic Products CA 15-3 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS CA 15-3 assay).
-
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
-
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
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)
Equivalence was demonstrated using currently commercially available reagents along with patient specimens from patients who are normal, undergoing therapeutic and/or undergoing diagnostic evaluation. In clinical studies of apparently healthy individuals, patients with cancer and patients with a variety of non-malignant diseases, the VITROS CA 15-3 assay exhibited distribution results that parallel expected distributions for these patient types.
The serial monitoring study demonstrated the clinical utility of the VITROS CA 15-3 assay for monitoring for recurrence of disease in patients previously treated for stage II or stage III breast cancer and for monitoring response to treatment of breast cancer patients with metastatic disease.
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.
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.
0
ADMINISTRATIVE l
1.1 510(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: J
1. Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-3607
Contact Person: Anne Zavertnik
Date 510(k) prepared: October 19, 1998
2. Device Name
Trade or Proprietary Name: VITROS Immunodiagnostic Products CA 15-3 Calibrators VITROS Immunodiagnostic Products CA 15-3 Reagent Pack
Common Name: CA 15-3 assay
Classification Name: test for the in vitro quantitative determination of DF3-defined antigen in serum or plasma.
3. Comparitor Device
The VITROS Immunodiagnostic Products CA 15-3 assay is substantially equivalent to the Centocor CA 15-3 RIA (K963803).
4. Device Description
The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
-
- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products CA 15-3 Reagent Pack, VITROS Immunodiagnostic Products CA 15-3 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS CA 15-3 assay).
1 - 1
- The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products CA 15-3 Reagent Pack, VITROS Immunodiagnostic Products CA 15-3 Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS CA 15-3 assay).
1
-
- The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
-
- Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).
The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
5. Device Intended Use
The VITROS®CA 15-3 is an in vitro assay intended for the quantitative measurement of DF3 defined antigen in serum or plasma (EDTA or heparin) from patients previously treated for stage II or stage III breast cancer. Serial test results obtained with the VITROS CA 15-3 assay, in patients who are clinically free of disease, should be used in conjunction with all relevant information derived from diagnostic test, physical examination and full medical history in accordance with appropriate patient management procedures used for early detection of recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring progression or response to treatment.
6. Comparison to Comparitor Device
The VITROS Immunodiagnostic Products CA 15-3 assay is substantially equivalent to Centocor CA 15-3 RIA (comparitor device), which was approved by FDA (K963803) for IVD use.
The relationship between the VITROS CA 15-3 assay and the comparitor device, determined by Bablock Passing regression, is:
VITROS CA 15-3 assay = 0.945 x [Centocor CA 15-3 RIA] + 1.55 (U/mL). with a correlation coefficient of 0.978.
Comparisons of the VITROS CA 15-3 assay and the comparitor device were performed with samples from a variety of clinical categories.
In addition to the studies mentioned above, tests were performed to obtain analytical sensitivity, specificity, precision, dilution and expected values. Refer to the VITROS CA 15-3 assay package insert for VITROS CA 15-3 assay results.
Table 1 lists the similarities and differences of the device characteristics between the VITROS CA 15-3 assay with the comparitor device, Centocor CA 15-3 RIA assay:
2
Table 1 List of the assay characteristics
| Device
Characteristic | VITROS CA 15-3 assay | Comparitor
Device |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Calibration range | 0 - 500 U/mL | 0 - 200 U/mL |
| Basic principle | Solid phase immunoassay | Solid phase
radioimmunoassay |
| Tracer | Enzyme labeled | Radioactive tracer |
| Sample type | Serum, plasma (heparin or
EDTA) | Serum, plasma |
| Antibody | 1) Mouse monoclonal anti-
DF3 antigen antibody in
biotinylated antibody
reagent
-
Mouse monoclonal anti-
DF3 antigen antibody in
conjugate reagent | 1) Mouse monoclonal
115D8 antibody coated
onto beads -
Mouse monoclonal
DF3 antibody labeled
with I125 |
| Sample volume | 10 µL | 20 µL |
| Incubation time and
temperature | First incubation 16
minutes at 37°C with
shaking
Second incubation 16
minutes at 37°C with
shaking | First incubation 2 hours at
room temperature
Second incubation 3
hours at room temperature |
7. Conclusions
The data presented in the premarket notification demonstrate that the VITROS CA 15-3 assay performs substantially equivalent to the cleared comparitor device.
Equivalence was demonstrated using currently commercially available reagents along with patient specimens from patients who are normal, undergoing therapeutic and/or undergoing diagnostic evaluation. In clinical studies of apparently healthy individuals, patients with cancer and patients with a variety of non-malignant diseases, the VITROS CA 15-3 assay exhibited distribution results that parallel expected distributions for these patient types.
The serial monitoring study demonstrated the clinical utility of the VITROS CA 15-3 assay for monitoring for recurrence of disease in patients previously treated for stage II or stage III breast cancer and for monitoring response to treatment of breast cancer patients with metastatic disease.
The data presented in the premarket notification provide a reasonable assurance that the VITROS CA 15-3 assay is safe and effective for the stated intended use.
3
Image /page/3/Picture/2 description: The image shows a partial view of a logo or emblem, featuring a stylized design of three curved lines stacked on top of each other. The lines appear to be thicker at the top and taper slightly as they descend. To the left of the design, a portion of text is visible, oriented vertically. The text is partially cut off, but the visible letters suggest it is part of a larger phrase or title.
FEB 2 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101
Re: K983690 Trade Name: VITROS Immunodiagnostic Products CA 15-3 Calibrators VITROS Immunodiagnostic Products CA 15-3 Reagent Pack Regulatory Class: II Product Code: MOI December 14, 1998 Dated: Received: December 16, 1998
Dear Ms. Zavertnik:
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 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). 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 requirements, 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 In addition, FDA may publish further requlatory action. announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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 requlations.
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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 (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
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Page 1 of 1
1.3 Indications For Use Statement
K 9431,90
510(k) Number (if known):
Device Name:
VITROS Immunodiagnostic Products CA 15-3 Reagent Pack VITROS Immunodiagnostic Products CA 15-3 Calibrators
Indications for Use:
The VITROS®CA 15-3 is an in vitro assay intended for the quantitative measurement of DF3 defined antigen in serum or plasma (EDTA or heparin) from patients previously treated for stage II or stage III breast cancer. Serial test results obtained with the VITROS CA 15-3 assay, in patients who are clinically free of disease, should be used in conjunction with all relevant information derived from diagnostic test, physical examination and full medical history in accordance with appropriate patient management procedures used for early detection of recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring progression or response to treatment.
Petu G. Moir
Division Sign-Off)
Division of Clinical Laboratory Devices K983698
510(k) Number
(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 _
(Optional Format 1-2-96)