CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K013568 · Bayer Corp. · DHX · Dec 21, 2001 · Immunology

Device Facts

• Record ID: K013568
• Device Name: CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
• Applicant: Bayer Corp.
• Product Code: DHX · Immunology
• Decision Date: Dec 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

This in vitro immunoassay is intended to quantitatively measure CEA in human serum using ADVIA IMS CEA Assay on a Bayer ADVIA® IMS™. Carcinoembryonic Antigen (CEA) is a protein polysaccharide normally present at very low concentrations in the blood of healthy adults. Colorectal cancer and a variety of neonlantic and other disease processes cause significant elevation of CEA, thus issued as a tumor marker. CEA assay is designed to aid in the management and prognosis of cancer patients in whom changing concentrations of CEA are observed.

Device Story

ADVIA IMS CEA Assay is an in vitro diagnostic immunoassay for human serum; measures Carcinoembryonic Antigen (CEA) concentrations. Used on Bayer ADVIA® Integrated Modular System (IMS™) in clinical laboratory settings. System processes serum samples to quantify CEA levels; results used by physicians to monitor cancer patients, assess prognosis, and manage disease progression. Provides quantitative output (ng/mL) to assist clinical decision-making regarding cancer therapy and follow-up. Benefits patients through longitudinal monitoring of tumor marker concentrations.

Clinical Evidence

Bench testing only. Correlation study (N=89) comparing ADVIA IMS to Immuno 1 yielded a regression equation of Y = 0.973X + 0.093 with an R-value of 0.998. Analytical range is 0.2–100 ng/mL. Imprecision studies showed Total CVs ranging from 1.8% to 3.0% across levels of 2.05–16.85 ng/mL. Interference testing for hemoglobin, lipids, bilirubin, IgG, and albumin showed minimal effect (≤2.5% change).

Technological Characteristics

In vitro immunoassay for use on the Bayer ADVIA® IMS™ platform. Analytical range: 0.2–100 ng/mL. Quantitative measurement of CEA protein polysaccharide. Reagents and calibrators specific to the ADVIA IMS system. No specific materials of construction or software architecture details provided beyond standard clinical chemistry analyzer integration.

Indications for Use

Indicated for the quantitative measurement of Carcinoembryonic Antigen (CEA) in human serum to aid in the management and prognosis of cancer patients by monitoring CEA concentrations. Not indicated for cancer screening in the general population.

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

• Immuno 1 CEA Assay (P940030)

Submission Summary (Full Text)

{0}------------------------------------------------

# DEC 21 2001

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CEA Assay for Bayer ADVIA® Integrated Modular System (IMS)™

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: 4013568

## 1. Intended Use

This in vitro immunoassay is intended to quantitatively measure CEA in human serum using ADVIA IMS CEA Assay on a Bayer ADVIA® IMS™. Carcinoembryonic Antigen (CEA) is a protein polysaccharide normally present at very low concentrations in the blood of healthy adults. Colorectal cancer and a variety of neonlantic and other disease processes cause significant elevation of CEA, thus issued as a tumor marker. CEA assay is designed to aid in the management and prognosis of cancer patients in whom changing concentrations of CEA are observed.

## 2. Predicate Device

| T T P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P<br>Product Name | | Reagent Part # Calibrator Part # | K # |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------------------------|-----------------------------|
| Immuno 1 CEA Assay | T01-3184-51 T03-3188-01 | | P940030; down classified to |
| | | | 210(k) |

### 3. Device / Method

| Product Name | Reagent Part # / BAN Number | Calibrator Part # / BAN Number |
|---------------------|---------------------------------------------------------------|--------------------------------|
| ADVIA IMS CEA Assay | B42-3897-42 /<br>00610885 (100 tests)<br>01075029 (250 tests) | B43-3929-01 /<br>02918372 |

#### Imprecision

| ADVIA IMS | Immuno 1 | | |
|------------------|-------------|------------------|-------------|
| Level<br>(ng/mL) | Total CV(%) | Level<br>(ng/mL) | Total CV(%) |
| 2.05 | 3.0 | 2 | 5.3 |
| 10.76 | 2.2 | 12 | 4.3 |
| 16.85 | 1.8 | 24 | 4.3 |

#### Correlation (Y= ADVIA IMS, X=comparison system)

| Specimen type | Comparison System (X) | N | Regression Equation | Syx (ng/mL) | R | Sample Range (ng/mL) |
|---------------|-----------------------|----|---------------------|-------------|-------|----------------------|
| Serum | Immuno 1 | 89 | $0.973 * X + 0.093$ | 1.019 | 0.998 | 0.51-76.25 |

#### Interfering Substances

| Interfering<br>Substance | Interfering Substance<br>Concentration<br>mg/dL | CEA<br>Concentration<br>(ng/mL) | Effect<br>(% change) |
|--------------------------|-------------------------------------------------|---------------------------------|----------------------|
| Hemoglobin | 1000 | 2.01 | 0.4 |
| Lipids (Triglycerides) | 1000 | 1.6 | 1.8 |
| Bilirubin | 25 | 2.11 | 1.2 |
| IgG | 6.0 | 1.85 | 1.2 |
| Albumin | 6.5 | 1.71 | 2.5 |

{1}------------------------------------------------

## Analytical Range

0.2 – 100 ng/mL

## Minimum Detectable Concentration

| ADVIA IMS<br>(ng/mL) | Immuno 1<br>(ng/mL) |
|----------------------|---------------------|
| 0.2 | 0.2 |

# 4. Conclusion

Performance of the ADVIA IMS CEA Assay on the prodicate device (Immuno 1) and is within proposed
performance of the CEA Assay on the prodicate device (Immuno 1) and is within performance of the OEFF Prosey one effectiveness issues have been raised.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 2001

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

k013568 Re:

> Trade/Device Name: Carcenoembroyonic Antigen Assay for the Advia IMS Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: DHX Dated: October 24, 2001 Received: October 26, 2001

Dear Dr. Edds:

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. Iisting 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 -

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 nothication. The PDA Inding of bacalantan sour 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 1 If you desire specific acvice for your do vices), please contact the Office of Compliance at additionally 807.10 for m vide diaglions on the promotion and advertising of your device, [phone]. Tructionally for use at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionate assistance at its toll-free number [phone] or Manufacturers International and Sells ss "http://www.fda.gov/odrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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

{4}------------------------------------------------

#### K0135 & 510(k) Number:

Device Name: Carcenoembroyonic Antigen Assay for the Advia IMS

Indications for Use:

The Bayer ADVIA® IMS™ CEA assay is an in vitro diagnostic device intended to The Buyer ADP In THE - SEPT abonny in antigen (CEA) in human serum. CEA test results qualitiatively incasure caremotified by monitoring CEA concentrations. CEA testing is ald in the management or cancedure to detect cancer in the general population.

(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_17

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-CounterUse_

(Optional Format 1-2-96)