(15 days)
The Access CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems. CEA measured by the Access Immunoassay Systems is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.
The Access® CEA reagents consist of reagent packs, calibrators, bi-level controls, substrate and wash buffer.
The provided text describes a 510(k) premarket notification for a modification to the Access® CEA Reagents on the Access® Immunoassay Systems. The modification involves adding a new instrument platform, the Beckman Coulter UniCel™ Dxl 800 Access® Immunoassay System, to the existing family of Access Immunoassay Systems.
The study aimed to demonstrate that the Access CEA assay on the Dxl system is substantially equivalent to the Access CEA assay on the Access 2 system.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the Access CEA assay met established acceptance criteria for "method comparison, precision and analytical sensitivity." However, the specific numerical acceptance criteria for these parameters (e.g., specific ranges for agreement, coefficients of variation, or limits of detection) are not detailed in the provided summary. Similarly, the reported performance values from the studies (e.g., actual method comparison results, precision data, or analytical sensitivity figures) are not provided. The text only offers a general statement of compliance.
| Acceptance Criteria (Specifics Not Provided) | Reported Device Performance (Specifics Not Provided) |
|---|---|
| Method Comparison (e.g., % agreement, bias limits) | Met established criteria |
| Precision (e.g., %CV, within-run, between-run) | Met established criteria |
| Analytical Sensitivity (e.g., Limit of Detection) | Met established criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the method comparison, precision, or analytical sensitivity studies. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is an immunoassay for quantitative determination of Carcinoembryonic Antigen (CEA) levels, which relies on a chemical reaction to produce a numerical result. Therefore, there is no ground truth established by human experts in the same way it would be for an imaging device requiring expert interpretation. The "ground truth" for evaluating this device would be established by reference methods or established analytical standards. The document does not provide details on how this was established for the comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since this is an immunoassay seeking substantial equivalence to a predicate device, the "adjudication method" in the context of human expert review is not applicable. The evaluation relies on quantitative analytical comparisons, not human interpretation consensus.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for medical imaging or diagnostic interpretation tasks where human readers are involved. This device is an automated immunoassay system, and its evaluation focuses on analytical performance metrics rather than human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described (method comparison, precision, and analytical sensitivity) inherently represent standalone performance of the algorithm/device. The device itself performs the quantitative determination of CEA levels. Human involvement would be in operating the instrument and interpreting the numerical output, but the performance being evaluated is that of the automated system. The document states that the new system (Dxl) uses the same reagents and calibrators as the predicate (Access 2), implying that the algorithm/assay itself is unchanged, and the evaluation is on the new instrument platform's ability to produce equivalent results.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these types of studies would typically be established by:
- Predicate device results: For method comparison, the results from the legally marketed Access® CEA Reagents on the Access® Immunoassay Analyzer (K981985, K991707) would serve as the comparator or "reference."
- Reference materials/standards: For precision and analytical sensitivity, the device would be tested against known concentrations of CEA or characterized control materials.
The document does not explicitly state the type of ground truth used beyond indicating that method comparison was against the predicate device.
8. The sample size for the training set
The document does not mention a training set. This is because the device is an immunoassay kit/system, not an artificial intelligence or machine learning algorithm that requires a distinct training phase. The "training" of such a system would involve its initial development and validation by the manufacturer, but not in the context of a dataset used to optimize an AI model.
9. How the ground truth for the training set was established
As there is no "training set" in the context of an AI/ML algorithm for this immunoassay device, this question is not applicable.
{0}------------------------------------------------
Confidential
MAY 0 6 2003
(Page 1 of 2)
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.
510(k) Number_(503 1270
510(K) Summary
Date Prepared: April 17, 2003
| Submitter | Contact Person |
|---|---|
| Beckman Coulter, Inc | Lynn Weist |
| 1000 Lake Hazeltine Drive | Staff Regulatory Affairs Specialist |
| Chaska, MN 55318 | Phone: 952-368-1271Fax: 952-368-7710 |
General Information
1.4
| Proprietary Name | Access® CEA Reagents on the Access® ImmunoassaySystems |
|---|---|
| Classification Name | Carcinoembryonic Antigen (CEA) Immunological TestSystem for Management of Cancers |
| Device Class | Class II |
| Legally Marketed(Unmodified) Device | Access® CEA Reagents on the Access® ImmunoassayAnalyzer (K981985, cleared 09/24/98; K991707, cleared06/01/99; Access 2 Add-to-File Letter, dated 04/24/01) |
Device Description
The Access® CEA reagents consist of reagent packs, calibrators, bi-level controls, substrate and wash buffer.
Intended Use
The Access CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems. CEA measured by the Access Immunoassay Systems is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.
{1}------------------------------------------------
510(k) Summary
(Page 2 of 2)
Description of the Modification to the Legally Marketed Device
The modification to the Access CEA reagents is to add a new instrument platform, the Beckman Coulter UniCel™ Dxl 800 Access® Immunoassay System, to the family of Access Immunoassay Systems. The Dxl System is a new model within the same model series of Access Immunoassay Systems manufactured and distributed by Beckman Coulter, Inc. The Dxl System was cleared for marketing by FDA on January 28, 2003, K023764.
The DxI uses the same Access CEA reagents and calibrators, packaged the same as for the Access 2 System. The formulations of the substrate and wash buffer used with the Access CEA assay are unchanged. There are no changes to the intended uses, technical specifications or final performance specifications and claims for the assay.
Supporting Data
In order to demonstrate that the Access CEA assay on the Dxl system is substantially equivalent to the Access CEA assay on the Access 2 system, method comparison, precision and analytical sensitivity studies were conducted. The Access CEA assay met the established acceptance criteria for method comparison, precision and analytical sensitivity.
Conclusion
The information provided in this submission supports a substantial equivalence determination, and therefore, 510(k) premarket notification clearance of the Access CEA Reagents on the UniCel Dxl 800 Access Immunoassay System.
{2}------------------------------------------------
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized image of three human profiles facing to the right, one behind the other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lynn Weist Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
MAY 0 6 2003
Re: K031270
Trade/Device Name: Access® CEA Reagents on the Access® Immunoassay Systems Regulation Number: 21 CFR § 866.6010 Regulation Name: System Test, Carcinoembryonic Antigen Regulatory Class: II Product Code: DHX Dated: April 17, 2003 Received: April 22, 2003
Dear Ms. Weist:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
{3}------------------------------------------------
Page 2 –
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
1.3 Indications for Use Statement
| 510(k) Number (if known): | K031270 |
|---|---|
| --------------------------- | --------- |
PAGE 1 OF 1Device Name: Access® CEA Reagents on the Access® Immunoassay Systems
Indications for Use:
The Access CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems. CEA measured by the Access Immunoassay Systems is used as an aid in the management of cancer palients in whom changing CEA concentrations have been observed.
(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 | K0 31270 |
|---|---|
| --------------- | ---------- |
| Prescription Use | ✓ |
|---|---|
| (per 21 CFR 801.109) |
OR
| Over-the-Counter Use | |
|---|---|
| (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.