(71 days)
No
The document describes a standard immunoassay system and does not mention any AI or ML components in the device description or performance studies.
No
This device is an in vitro diagnostic assay used for the quantitative measurement of a biomarker (CEA) to aid in the prognonsis and management of cancer patients; it does not directly treat or prevent a disease.
Yes
The device is an in vitro assay intended for the quantitative measurement of carcinoembyronic antigen (CEA) to aid in the prognosis and management of cancer patients, which falls under diagnostic purposes.
No
The device description clearly outlines hardware components (VITROS ECi Immunodiagnostic System instrumentation, coated microwells) and reagents, indicating it is 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® CEA is an in vitro assay intended for the quantitative measurement of carcinoembyronic antigen (CEA) in human serum and plasma. This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The "Device Description" further clarifies that the system uses luminescence in the determination of selected analytes in human body fluids, commonly serum, plasma or urine. This reinforces its use with biological samples outside of the body.
- Performance Studies: The "Summary of Performance Studies" describes comparisons performed with samples from a variety of clinical categories, indicating the testing of human specimens.
The information provided clearly demonstrates that this device is designed to perform tests on biological samples taken from the human body to aid in the diagnosis and management of patients, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
The Vitros® CEA is an in vitro assay intended for the quantitative measurement of carcinoembyronic antigen (CEA) in human serum and plasma (EDTA or heparin) to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.
Product codes
DHX
Device Description
The VITROS ECi Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma or urine. Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: - 1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products CEA Reagent Pack, VITROS Immunodiagnostic Products CEA Calibrators, which are combined by the VITROS ECi System to perform the VITROS CEA assay). - 2. The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS ECi System was cleared for market by a separate 510(k) pre-market notification (K962919). - 3. 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 (K964310). The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 malignant disease and patients with a variety of non-malignant diseases, the VITROS CEA assay exhibited distribution results that parallel expected distributions for these patient types. The serial monitoring study demonstrated that the VITROS CEA assay is substantial equivalent to the predicate device in patients previously treated for colorectal cancer.
Key Metrics
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Predicate Device(s)
P830066
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
ADMINISTRATIVE 1
510(k) Summary 1.1
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: 1990943
1. Submitter name, address, contact
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 (716) 453-3790
Contact Person: Anne Zavertnik
Date 510(k) prepared: March 19, 1999
2. Device Name
Trade or Proprietary Name: VITROS® Immunodiagnostic Products CEA Calibrators
VITROS® Immunodiagnostic Products CEA Reagent Pack
Common Name: CEA assay
Classification Name: test for the in vitro quantitative determination of carcinoembyronic antigen in serum or plasma.
3. Predicate Device
The VITROS Immunodiagnostic Products CEA assay is substantially equivalent to the Abbott AxSYM CEA Assay (P830066).
4. Device Description
The VITROS ECi Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma or urine. 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 CEA Reagent Pack, VITROS Immunodiagnostic Products CEA Calibrators, which are combined by the VITROS ECi System to perform the VITROS CEA assay).
1
-
- The VITROS ECi Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS ECi 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 (K964310).
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® CEA is an in vitro assay intended for the quantitative measurement of carcinoembyronic antigen (CEA) in human serum and plasma (EDTA or heparin) to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.
6. Comparison to Predicate Device
The VITROS Immunodiagnostic Products CEA assay is substantially equivalent to Abbott AxSYM CEA Assay (predicate device), which was approved by FDA (P830066) for IVD use.
The relationship between the VITROS CEA assay and the predicate device, determined by Passing and Bablok, is:
VITROS CEA assay = 1.06 x [Abbott AxSYM CEA assay] + 0.124 (ng/mL), with a correlation coefficient of 0.977.
Comparisons of the VITROS CEA assay and the predicate 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 CEA assay package insert for VITROS CEA assay results.
Table 1 lists the similarities and differences of the device characteristics between the VITROS CEA assay with the predicate device:
2
| Device
Characteristic | VITROS CEA assay | Predicate
Device |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Calibration range
(reportable range) | 0 - 400 ng/mL | 0.5 - 500ng/mL |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Sample type | Serum, plasma (heparin or EDTA) | Serum, plasma (heparin or EDTA) |
| Antibody | 1) mouse monoclonal anti-
CEA in biotinylated
antibody reagent
-
mouse monoclonal anti-
CEA in conjugate reagent | 1) mouse monoclonal anti-
CEA coated Microparticles -
mouse monoclonal anti-
CEA in conjugate reagent |
| Sample volume | 20 µL | 150 µL |
| Analytical sensitivity | 0.3 ng/mL | 0.5 ng/mL |
Table 1 List of the assay characteristics
7. Conclusions
The data presented in the premarket notification demonstrate that the VITROS CEA assay performs substantially equivalent to the approved predicate 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 malignant disease and patients with a variety of non-malignant diseases, the VITROS CEA assay exhibited distribution results that parallel expected distributions for these patient types.
The serial monitoring study demonstrated that the VITROS CEA assay is substantial equivalent to the predicate device in patients previously treated for colorectal cancer.
The data presented in the premarket notification provide a reasonable assurance that the VITROS CEA assay is safe and effective for the stated intended use.
3
Image /page/3/Picture/0 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 coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUN 1 1099 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: K990943 Trade Name: VITROS® Immunodiagnostic Products CEA Calibrators VITROS® Immunodiagnostic Products CEA Reagent Pack Regulatory Class: II Product Code: DHX Dated: March 19, 1999 March 22, 1999 Received:
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 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely vours.
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
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1.2 Indications For Use Statement
Page 1 of 1
510(k) Number (if known): K990943
Device Name: VITROS Immunodiagnostic Products CEA Reagent Pack
VITROS Immunodiagnostic Products CEA Calibrators
Indications for Use: The Vitros® CEA is an in vitro assay intended for the
quantitative measurement of carcinoembryonic antigen (CEA) in
human serum and plasma (EDTA or heparin) to aid in the
prognosis and management of cancer patients in whom changing
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
concentrations of CEA are observed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K990943 |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |