(63 days)
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.
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.
Here's an analysis of the provided text regarding the Abbott ARCHITECT™ CEA, focusing on acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Abbott ARCHITECT™ CEA assay are implicitly defined by its performance comparison to a legally marketed predicate device, the Abbott AxSYM® CEA assay. The study aims to demonstrate substantial equivalence, meaning its performance is comparable to the predicate.
| Performance Metric | Acceptance Criteria (Predicate Performance) | Reported Device Performance (ARCHITECT CEA vs. AxSYM CEA) |
|---|---|---|
| Correlation Coefficient | High correlation (not explicitly stated, but implied by typical IVD equivalence studies which aim for >0.95 or >0.97) | 0.991 (least squares and Passing-Bablok) |
| Slope (Least Squares) | Near 1.0 (indicating proportional agreement) | 0.92 (95% CI: 0.91 to 0.93) |
| Y-intercept (Least Squares) | Near 0.0 (indicating no constant bias) | 0.85 ng/mL (95% CI: 0.01 to 1.69) |
| Slope (Passing-Bablok) | Near 1.0 | 0.97 (95% CI: 0.96 to 0.98) |
| Y-intercept (Passing-Bablok) | Near 0.0 | 0.28 ng/mL (95% CI: 0.26 to 0.30) |
| Distribution of CEA concentrations across various conditions | Similar to predicate | Similar distribution (qualitative statement) |
| Trending in monitoring cancer patients | Similar to predicate | Similar trending (qualitative statement) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: 1,069 specimens
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that it uses banked specimens to compare the two assays. Prospective data collection is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable / not provided. This study is a method comparison study between two diagnostic assays, not a study evaluating human interpretation against a ground truth. Therefore, there's no mention of experts required to establish a diagnostic ground truth for the specimens. The 'ground truth' here is essentially the measurement from the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. As this is a method comparison study between two assays, there's no human interpretation or subjective assessment that would require an adjudication method. The values obtained from each assay are quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not a MRMC study. It is a direct comparison of a new automated diagnostic assay (ARCHITECT CEA) against an existing automated diagnostic assay (AxSYM CEA) using patient samples. It does not involve human readers interpreting images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, implicitly. The entire study reflects the standalone performance of the ARCHITECT CEA assay, as it directly measures CEA levels in samples. The comparison is against another automated assay, not against human interpretation. The "algorithm" here refers to the immunoassay technology itself and its automated processing on the ARCHITECT i System.
7. The Type of Ground Truth Used
- Comparison to a Predicate Device. The "ground truth" in this context is the performance of the legally marketed predicate device, the Abbott AxSYM® CEA assay. The study aims to show that the new ARCHITECT CEA assay produces results that are statistically comparable and clinically similar to the established predicate. It is not an absolute ground truth like pathology for a cancer diagnosis, but rather a comparative ground truth for assay performance.
8. Sample Size for the Training Set
- Not explicitly stated/not applicable in this context. The document describes a comparison study, not a machine learning model that requires a distinct "training set" in the conventional sense. The "training" for the ARCHITECT CEA assay would involve internal assay development, optimization, and calibration (which is mentioned as being done with ARCHITECT CEA Calibrators), but the specific sample size for such activities is not provided as part of this substantial equivalence submission. The 1,069 specimens are used for the comparison (test) phase.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As indicated above, a distinct "training set" with established ground truth for a machine learning model is not described in this document. The calibration of the ARCHITECT CEA assay is mentioned: "ARCHITECT CEA is calibrated with ARCHITECT CEA Calibrators." The establishment of these calibrator values would involve a separate, internal process by the manufacturer, typically traceable to reference materials or established methods.
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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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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.
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| 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) |
§ 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.