Access CEA

K223921 · Beckman Coulter, Inc. · DHX · Sep 22, 2023 · Immunology

Device Facts

• Record ID: K223921
• Device Name: Access CEA
• Applicant: Beckman Coulter, Inc.
• Product Code: DHX · Immunology
• Decision Date: Sep 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

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.

Device Story

Access CEA is a two-site immunoenzymatic sandwich assay using mouse monoclonal anti-CEA antibodies. It utilizes paramagnetic particles and chemiluminescent detection to quantify CEA in human serum. The assay is designed for use on Beckman Coulter's Dxl 9000 Access Immunoassay Analyzer. It is intended for clinical laboratory use by trained personnel. The device transforms patient serum samples into quantitative CEA concentration values. Healthcare providers use these results to monitor cancer patients, specifically to track changes in CEA levels over time, which aids in clinical management decisions. The assay provides a standardized, automated method for longitudinal monitoring of disease status.

Clinical Evidence

Bench testing only. Method comparison study (n=153) demonstrated high correlation with the predicate (R=1.00, slope 0.98). Imprecision studies (CLSI EP-05-A3) showed within-laboratory CVs ranging from 2.5% to 5.2% across the measuring range (0.45–865 ng/mL). Analytical performance established: LoB 0.09 ng/mL, LoD 0.1 ng/mL, and LoQ 0.2 ng/mL. Linearity confirmed across the 0.2–1,000 ng/mL range.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Two-site immunoenzymatic sandwich format using mouse monoclonal anti-CEA antibodies. Automated operation on Dxl 9000 Access Immunoassay Analyzer. Measuring range 0.2–1,000 ng/mL. Reagents stable at 2–10°C for 28 days. Uses Lumi-Phos PRO substrate.

Indications for Use

Indicated for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum to aid in the management of cancer patients experiencing changing CEA concentrations.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Access CEA (K991707)
• Access CEA (K981985)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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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 ([e-mail]) or phone [phone] 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) |
|--------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] Email: [e-mail]

#### Alternate Contact:

Kuljeet Kaur, Senior Manager Regulatory Affairs Phone: [phone] Email: [e-mail]

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<br>Access Immunoassay Analyzer<br>(Predicate) | Access CEA Assay on<br>Dxl 9000 Access<br>Immunoassay Analyzer<br>(Candidate) |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Intended use | The Access CEA assay is a<br>paramagnetic particle,<br>chemiluminescent immunoassay for<br>the quantitative determination of<br>Carcinoembryonic Antigen (CEA)<br>levels in human serum, using the<br>Access Immunoassay Systems.<br>CEA measured by the Access<br>Immunoassay Systems is used as<br>an aid in the management of cancer<br>patients in whom changing CEA<br>concentrations have been observed. | Same |
| Analyte Measured | Carcinoembryonic Antigen (CEA) in<br>human serum | Same |
| Technology | One-step sandwich | Same |
| Format | Chemiluminescent | Same |
| Method | Automated | Same |
| Calibrators | Multi-point calibrators containing<br>purified CEA Human in a phosphate<br>buffered BSA matrix with<br>preservatives. | Same |

## Comparison of Technological Characteristics to the Predicate

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| Characteristic | Access CEA on<br>Access Immunoassay Analyzer<br>(Predicate)<br><br>Access CEA Assay on<br>Dxl 9000 Access<br>Immunoassay Analyzer<br>(Candidate) |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibration | Utilizes a stored calibration curve<br>Same |
| QC Controls | Bi-level controls containing human<br>CEA in a phosphate buffered BSA<br>matrix with preservatives<br>Same |
| Sample Type | Serum<br>Same |
| Antibody | Monoclonal (mouse) anti-human<br>CEA antibodies<br>Same |
| Reagent Stability | Stable at 2 to 10°C for 28 days after<br>initial use<br>Same |
| Measuring Range | ~0.1 – 1,000 ng/mL<br>0.2 — 1,000 ng/mL |
| Substrate | Access Substrate<br>Lumi-Phos PRO substrate |
| Instrument | Access 2 Immunoassay system<br>Dxl 9000 Access<br>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<br>Range* (ng/mL) | Slope | Slope 95%<br>Cl | Intercept | Intercept 95%<br>Cl | Correlation<br>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<br>(Within-run) | | Between-run | | Between-day | | Within- Laboratory<br>(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.