(267 days)
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No
The summary describes a standard immunoassay for measuring CEA levels and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) assay designed to quantify CEA levels, which is used as an aid in managing cancer patients. It does not directly treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section states that the assay is "used as an aid in the management of cancer patients," which indicates its role in providing information for clinical decision-making, a characteristic of diagnostic devices.
No
The device is a paramagnetic particle, chemiluminescent immunoassay, which is a laboratory test kit containing reagents and designed for use on specific immunoassay analyzers. This involves physical components and chemical reactions, 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) levels in human serum". This involves testing a sample taken from the human body (in vitro) to provide diagnostic information.
- Device Description: It describes a "paramagnetic particle, chemiluminescent immunoassay" and a "two-site immunoenzymatic 'sandwich' assay". These are common techniques used in laboratory settings to analyze biological samples.
- Sample Type: The assay is performed on "human serum". Serum is a biological fluid obtained from blood, which is a sample taken from the human body.
- Purpose: The results are used "as an aid in the management of cancer patients". This indicates the test provides information used in the diagnosis, monitoring, or management of a disease.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 patients in whom changing CEA concentrations have been observed.
Product codes
DHX
Device Description
The Access CEA assay is a two-site immunoenzymatic "sandwich" assay using two mouse monoclonal anti-CEA antibodies (MAb) which react with different epitopes of CEA. The Access CEA reagent kit is in a liguid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators, and wash buffer.
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
Prescription Use
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
Method Comparison: A method comparison study was performed to compare the Access CEA Assay on Dxl 9000 Access Immunoassay Analyzer to the predicate device. A total of one hundred and fifty-three (153) serum samples falling within the measuring range of the Access CEA assay were evaluated. The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.10.
Imprecision: Verification studies were performed to determine the imprecision of the Access CEA assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based CLSI EP-05-A3 with multiple samples with minimum of three replicates in 2 runs per day for a minimum of 20 days.
Linearity: The Access CEA assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of 0.2 - 1,000 ng/mL.
Limit of Blank (LoB): The claimed LoB estimate for the Access CEA assay is 0.09 ng/mL on the Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): The claimed LoD estimate for the Access CEA assay is 0.1 ng/mL on the Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): The claimed LoQ determined for Access CEA assay is 0.2 ng/mL on the Dxl 9000 Access Immunoassay Analyzer.
Key Metrics
Method Comparison:
N: 153
Concentration Range* (ng/mL): 0.46 -1071 (Range is Access 2 values)
Slope: 0.98
Slope 95% Cl: 0.97 - 0.99
Intercept: 0.058
Intercept 95% Cl: 0.0015 - 0.17
Correlation Coefficient R: 1.00
Imprecision:
Sample 1 (Mean 0.45 ng/mL, N=126): Repeatability %CV 3.5, Between-run %CV 1.5, Between-day %CV 2.0, Within-Laboratory (Total) %CV 4.3
Sample 2 (Mean 5.1 ng/mL, N=120): Repeatability %CV 2.1, Between-run %CV 0.8, Between-day %CV 1.2, Within-Laboratory (Total) %CV 2.5
Sample 3 (Mean 11 ng/mL, N=126): Repeatability %CV 1.9, Between-run %CV 2.5, Between-day %CV 1.5, Within-Laboratory (Total) %CV 3.5
Sample 4 (Mean 89 ng/mL, N=120): Repeatability %CV 2.2, Between-run %CV 0.9, Between-day %CV 1.3, Within-Laboratory (Total) %CV 2.7
Sample 5 (Mean 153 ng/mL, N=120): Repeatability %CV 1.8, Between-run %CV 1.3, Between-day %CV 1.5, Within-Laboratory (Total) %CV 2.7
Sample 6 (Mean 525 ng/mL, N=120): Repeatability %CV 3.5, Between-run %CV 1.2, Between-day %CV 3.1, Within-Laboratory (Total) %CV 4.8
Sample 7 (Mean 865 ng/mL, N=120): Repeatability %CV 2.6, Between-run %CV 0.6, Between-day %CV 4.5, Within-Laboratory (Total) %CV 5.2
LoB: 0.09 ng/mL
LoD: 0.1 ng/mL
LoQ: 0.2 ng/mL
Predicate Device(s)
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.
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September 22, 2023
Beckman Coulter, Inc Kuljeet Kaur Manager, Regulatory Affairs 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re: K223921
Trade/Device Name: Access CEA Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: Class II Product Code: DHX Dated: August 23, 2023 Received: August 23, 2023
Dear Kuljeet Kaur:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying Mao -S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223921
Device Name Access CEA
Indications for Use (Describe)
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 Immunoasay Systems is used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, placed to the left of the company name. The text "BECKMAN" is on the top line and "COULTER" is on the bottom line, both in a bold, sans-serif font.
Access CEA 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: K223921
Submitter Name and Address:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Primary Contact:
Abhi Kannan, Staff Regulatory Affairs Phone: +1 (905) 556 0843 Email: Akannan01@beckman.com
Alternate Contact:
Kuljeet Kaur, Senior Manager Regulatory Affairs Phone: (952) 465-1914 Email: kkaur@beckman.com
Trade Name: Access CEA Common Name: Carcinoembryonic Antigen Assay Classification Name: Tumor-associated antigen immunological test system Classification Regulation: 21 CFR 866.6010 Classification Product Code: DHX
Predicate Device: Access CEA 510(k) numbers: K991707 and K981985
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Device Description
The Access CEA assay is a two-site immunoenzymatic "sandwich" assay using two mouse monoclonal anti-CEA antibodies (MAb) which react with different epitopes of CEA. The Access CEA reagent kit is in a liguid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators, and wash buffer.
Intended Use
The Access CEA assay is a paramaqnetic 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.
| Characteristic | Access CEA on
Access Immunoassay Analyzer
(Predicate) | Access CEA Assay on
Dxl 9000 Access
Immunoassay Analyzer
(Candidate) |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 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. | Same |
| Analyte Measured | Carcinoembryonic Antigen (CEA) in
human serum | Same |
| Technology | One-step sandwich | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibrators | Multi-point calibrators containing
purified CEA Human in a phosphate
buffered BSA matrix with
preservatives. | Same |
Comparison of Technological Characteristics to the Predicate
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| Characteristic | Access CEA on
Access Immunoassay Analyzer
(Predicate)
Access CEA Assay on
Dxl 9000 Access
Immunoassay Analyzer
(Candidate) |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibration | Utilizes a stored calibration curve
Same |
| QC Controls | Bi-level controls containing human
CEA in a phosphate buffered BSA
matrix with preservatives
Same |
| Sample Type | Serum
Same |
| Antibody | Monoclonal (mouse) anti-human
CEA antibodies
Same |
| Reagent Stability | Stable at 2 to 10°C for 28 days after
initial use
Same |
| Measuring Range | ~0.1 – 1,000 ng/mL
0.2 — 1,000 ng/mL |
| Substrate | Access Substrate
Lumi-Phos PRO substrate |
| Instrument | Access 2 Immunoassay system
Dxl 9000 Access
Immunoassay Analyzer |
Summary of Studies
Method Comparison: A method comparison study was performed to compare the Access CEA Assay on Dxl 9000 Access Immunoassay Analyzer to the predicate device. A total of one hundred and fifty-three (153) serum samples falling within the measuring range of the Access CEA assay were evaluated. The results of the within range method comparison study met the acceptance criteria of R2 ≥ 0.90 and slope 1.00 ± 0.10.
| N | Concentration
Range* (ng/mL) | Slope | Slope 95%
Cl | Intercept | Intercept 95%
Cl | Correlation
Coefficient R |
|-----|---------------------------------|-------|-----------------|-----------|---------------------|------------------------------|
| 153 | 0.46 -1071 | 0.98 | 0.97 - 0.99 | 0.058 | 0.0015 - 0.17 | 1.00 |
*Range is Access 2 values
Imprecision: Verification studies were performed to determine the imprecision of the Access CEA assay on the Dxl 9000 Access Immunoassay Analyzer using a protocol based CLSI EP-05-A3 with multiple samples with minimum of three replicates in 2 runs per day for a minimum of 20 days.
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| Concentration (ng/mL) | | Repeatability
(Within-run) | | Between-run | | Between-day | | Within- Laboratory
(Total) | | |
|-----------------------|-----|-------------------------------|------|-------------|------|-------------|------|-------------------------------|------|-----|
| Sample | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 126 | 0.45 | 0.02 | 3.5 | 0.01 | 1.5 | 0.01 | 2.0 | 0.02 | 4.3 |
| 2 | 120 | 5.1 | 0.10 | 2.1 | 0.04 | 0.8 | 0.06 | 1.2 | 0.13 | 2.5 |
| 3 | 126 | 11 | 0.2 | 1.9 | 0.3 | 2.5 | 0.2 | 1.5 | 0.4 | 3.5 |
| 4 | 120 | 89 | 1.9 | 2.2 | 0.8 | 0.9 | 1.1 | 1.3 | 2.4 | 2.7 |
| 5 | 120 | 153 | 2.8 | 1.8 | 1.9 | 1.3 | 2.3 | 1.5 | 4.1 | 2.7 |
| 6 | 120 | 525 | 18.5 | 3.5 | 6.6 | 1.2 | 16.0 | 3.1 | 25.3 | 4.8 |
| 7 | 120 | 865 | 22.4 | 2.6 | 5.3 | 0.6 | 38.6 | 4.5 | 45.0 | 5.2 |
Linearity: The Access CEA assay is linear on the Dxl 9000 Access Immunoassay Analyzer throughout the analytical measuring interval of 0.2 - 1,000 ng/mL.
Limit of Blank (LoB): The claimed LoB estimate for the Access CEA assay is 0.09 ng/mL on the Dxl 9000 Access Immunoassay Analyzer.
Limit of Detection (LoD): The claimed LoD estimate for the Access CEA assay is 0.1 ng/mL on the Dxl 9000 Access Immunoassay Analyzer.
Limit of Quantitation (LoQ): The claimed LoQ determined for Access CEA assay is 0.2 ng/mL on the Dxl 9000 Access Immunoassay Analyzer.
Substantial Equivalence Comparison Conclusion
Beckman Coulter's Access CEA Assay on the Dxl 9000 Access Immunoassay Analyzer is substantially equivalent to the Access CEA Assay on the Access Immunoassay System as demonstrated through the information and data provided in this submission. The performance testing presented in this submission provides evidence that the device is safe and effective in its intended use.