(63 days)
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No
The summary describes a standard immunoassay for quantitative determination of CEA. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The performance studies focus on correlation with a predicate device, which is typical for a traditional diagnostic assay.
No
The device is an in vitro diagnostic immunoassay used to measure CEA levels, which aids in prognosis and management, but it does not directly treat a medical condition.
Yes
The device is described as an "aid in the prognosis and management of cancer patients" because it measures Carcinoembryonic Antigen (CEA) in human samples, which is a biomarker used in the diagnostic process for cancer.
No
The device description clearly states it is a Chemiluminescent Microparticle Immunoassay (CMIA) and mentions components like calibrators and controls, indicating it is a laboratory assay kit with physical reagents, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Carcinoembryonic Antigen (CEA) in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: The description confirms it's a "Chemiluminescent Microparticle Immunoassay for the quantitative determination of CEA in human serum and plasma." This is a laboratory-based test method.
- Performance Studies: The performance studies describe correlation analyses using "specimens," which are biological samples.
All these points align 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, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The ARCHITECT CEA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Carcinoembryonic Antigen (CEA) in human serum and plasma on the ARCHITECT i System. The ARCHITECT CEA assay is to be used as an aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.
Product codes
DHX
Device Description
ARCHITECT CEA is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of CEA in human serum and plasma. ARCHITECT CEA is calibrated with ARCHITECT CEA Calibrators. ARCHITECT CEA Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.
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
Substantial equivalence has been demonstrated between the ARCHITECT CEA assay and the Abbott AxSYM® CEA assay, a microparticle enzyme immunoassay. A least squares correlation analysis between these two assays, using 1,069 specimens, yielded a correlation coefficient of 0.991, slope of 0.92 (95% confidence interval of 0.91 to 0.93), and y-intercept of 0.85 ng/mL (95% confidence interval of 0.01 to 1.69). A Passing-Bablok correlation analysis, using 1,069 specimens, vielded a correlation coefficient of 0.991, slope of 0.97 (95% confidence interval of 0.96 to 0.98), and y-intercept of 0.28 ng/mL (95% confidence interval of 0.26 to 0.30). Both assays show similar distribution of CEA concentrations across various conditions. Both assays also show similar trending when monitoring patients in whom changing concentrations of CEA are observed.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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510(k) Summary Abbott ARCHITECT™ CEA
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for Abbott ARCHITECT CEA constitutes data supporting a substantially equivalent determination.
ARCHITECT CEA is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of CEA in human serum and plasma. ARCHITECT CEA is calibrated with ARCHITECT CEA Calibrators. ARCHITECT CEA Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT i System.
Substantial equivalence has been demonstrated between the ARCHITECT CEA assay and the Abbott AxSYM® CEA assay, a microparticle enzyme immunoassay. The intended use of both assays is for the quantitative determination of CEA in human serum and plasma, and to be used as an aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed. Both assays use the same mouse monoclonal antibodies. A least squares correlation analysis between these two assays, using 1,069 specimens, yielded a correlation coefficient of 0.991, slope of 0.92 (95% confidence interval of 0.91 to 0.93), and y-intercept of 0.85 ng/mL (95% confidence interval of 0.01 to 1.69). A Passing-Bablok correlation analysis, using 1,069 specimens, vielded a correlation coefficient of 0.991, slope of 0.97 (95% confidence interval of 0.96 to 0.98), and y-intercept of 0.28 ng/mL (95% confidence interval of 0.26 to 0.30). Both assays show similar distribution of CEA concentrations across various conditions. Both assays also show similar trending when monitoring patients in whom changing concentrations of CEA are observed.
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In conclusion, these data demonstrate that the ARCHITECT CEA assay is as safe and effective as, and is substantially equivalent to, the AxSYM CEA assay.
Prepared and Submitted March 8, 1999 by:
Karen L. Gates, M.S. Senior Regulatory Specialist ADD Regulatory Affairs 1-847-938-0538
Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three wavy lines above three smaller wavy lines, resembling a symbol or abstract representation.
MAY 1 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Karen L. Gates, M.S. Senior Regulatory Specialist ADD Regualtory Affairs D9V6 AP31 200 Abbott Park Road Abbott Park, Illinois 60064-3537
Re: K990774 Trade Name: Abbott ARCHITECT™ CEA Regulatory Class: II Product Code: DHX Dated: March 8, 1999 Received: March 9, 1999
Dear Ms. Gates:
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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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 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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510(k) Number (if known): K990774 Device Name: Abbott ARCHITECT™ CEA Indications For Use:
The ARCHITECT CEA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Carcinoembryonic Antigen (CEA) in human serum and plasma on the ARCHITECT i System. The ARCHITECT CEA assay is to be used as an aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K970774 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |