ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

K031270 · Beckman Coulter, Inc. · DHX · May 6, 2003 · Immunology

Device Facts

• Record ID: K031270
• Device Name: ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
• Applicant: Beckman Coulter, Inc.
• Product Code: DHX · Immunology
• Decision Date: May 6, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

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.

Device Story

Access CEA reagents consist of reagent packs, calibrators, bi-level controls, substrate, and wash buffer. Device utilizes paramagnetic particle, chemiluminescent immunoassay technology to quantify CEA levels in human serum samples. System operates on Beckman Coulter Access Immunoassay Systems, including the UniCel Dxl 800. Used in clinical laboratory settings by trained personnel. Output is a quantitative CEA concentration value, which clinicians use to monitor disease progression or treatment response in cancer patients. Modification involves adding the Dxl 800 platform to existing Access system family; reagents and formulations remain unchanged from predicate.

Clinical Evidence

Bench testing only. Method comparison, precision, and analytical sensitivity studies were conducted to compare performance of the Access CEA assay on the UniCel Dxl 800 system versus the Access 2 system. Results met all established acceptance criteria.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Components: reagent packs, calibrators, bi-level controls, substrate, wash buffer. Platform: UniCel Dxl 800 Access Immunoassay System. No changes to assay formulation or technical specifications.

Indications for Use

Indicated for the quantitative determination of Carcinoembryonic Antigen (CEA) in human serum to aid in the management of cancer patients exhibiting 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 Reagents on the Access® Immunoassay Analyzer (K981985, K991707, Access 2 Add-to-File 04/24/01)

Reference Devices

• Beckman Coulter UniCel™ Dxl 800 Access® Immunoassay System (K023764)

Submission Summary (Full Text)

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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: [phone]<br>Fax: [phone] |

#### General Information

1.4

| Proprietary Name | Access® CEA Reagents on the Access® Immunoassay<br>Systems |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Carcinoembryonic Antigen (CEA) Immunological Test<br>System for Management of Cancers |
| Device Class | Class II |
| Legally Marketed<br>(Unmodified) Device | Access® CEA Reagents on the Access® Immunoassay<br>Analyzer (K981985, cleared 09/24/98; K991707, cleared<br>06/01/99; 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.

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## 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.

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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 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.

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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 [phone]. 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 [phone] or [phone] 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

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#### 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 | <div>✓</div> |
|----------------------|--------------|
| (per 21 CFR 801.109) | |

OR

| Over-the-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |