ELECSYS CEA ON THE ELECSYS 1010

K980887 · Boehringer Mannheim Corp. · DHX · Jun 29, 1998 · Immunology

Device Facts

• Record ID: K980887
• Device Name: ELECSYS CEA ON THE ELECSYS 1010
• Applicant: Boehringer Mannheim Corp.
• Product Code: DHX · Immunology
• Decision Date: Jun 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen (CEA) in human serum and plasma. The Elecsys CEA assay if further indicated for serial measurement of CEA to aid in the management of cancer patients. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

Device Story

Elecsys CEA Assay is an in vitro diagnostic immunoassay; utilizes electrochemiluminescence (ECLIA) technology. Input: human serum or plasma sample. Principle: sandwich immunoassay; sample reacts with biotinylated monoclonal CEA-specific antibody and ruthenium-labeled monoclonal CEA-specific antibody; complex binds to streptavidin-coated microparticles. Reaction mixture aspirated into measuring cell; microparticles magnetically captured on electrode; voltage application induces chemiluminescent emission measured by photomultiplier. Output: quantitative CEA concentration determined via calibration curve. Used in clinical laboratories on Boehringer Mannheim Elecsys 1010 or 2010 analyzers. Results assist clinicians in serial monitoring and management of cancer patients.

Clinical Evidence

Bench testing only. Precision evaluated using modified NCCLS protocols (N=60 per level). Method comparison against Elecsys 2010 (N=117) showed high correlation (r=0.995). Linearity established from 0.2 to 1000 ng/mL. No hook effect observed up to 200,000 ng/mL.

Technological Characteristics

Electrochemiluminescence immunoassay (ECLIA). Sandwich assay format using biotinylated and ruthenium-labeled monoclonal antibodies. Solid phase: streptavidin-coated microparticles. Detection: photomultiplier tube measuring chemiluminescence induced by electrode voltage. Connectivity: instrument-specific calibration via reagent bar code. Form factor: reagent kit for use on Elecsys 1010/2010 analyzers.

Indications for Use

Indicated for in vitro quantitative determination of CEA in human serum and plasma to aid in the management of cancer patients.

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

• Elecsys CEA on Elecsys 2010 (K964368)

Submission Summary (Full Text)

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JUN 2 9 1998

:

KC980887

## 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.<br>Submitter<br>name, address,<br>contact | Boehringer Mannheim Corporation<br>4300 Hacienda Drive<br>P.O. Box 9002<br>Pleasanton, CA 94566-0900<br>[phone]<br>Contact Person: Patricia M. Klimley<br>Date Prepared: March 6, 1998 |
| 2.<br>Device name | Proprietary name: Elecsys® CEA Assay<br>Common name: Electrochemiluminescence assay for the determination of<br>Carcinoembryonic antigen (CEA).<br>Classification name: Kit, Test , Carcinoembryonic antigen |
| 3.<br>Predicate device | The Boehringer Mannheim Elecsys® CEA on Elecsys® 1010 is substantially<br>equivalent to other products in commercial distribution intended for similar<br>use. Most notably it is substantially equivalent to the currently marketed<br>Elecsys® CEA on Elecsys® 2010. |
| 4.<br>Device<br>Description | The Elecsys® test principle is based on sandwich principle. Total duration of<br>assay: 18 minutes (37°C).<br>· 1st incubation (9 minutes): Sample (30 uL), biotinylated monoclonal CEA-<br>specific antibody (60 uL), and a monoclonal CEA-specific antibody labeled<br>with a ruthenium complex (60 µL) react to form a sandwich complex.<br>·2nd incubation (9 minutes): After addition of streptavidin-coated<br>microparticles (50 uL), the complex is bound to the solid phase via interaction<br>of biotin and streptavidin. |
| 4.<br>Device<br>Description<br>(con't) | •The reaction mixture is aspirated into the measuring cell where the<br>microparticles are magnetically captured onto the surface of the electrode.<br>Unbound substances are then removed with ProCell. Application of a voltage<br>to the electrode then induces chemiluminescent emission which is measured by<br>a photomultiplier (0.4 second read frame).<br>•Results are determined via a calibration curve which is instrument-specifically<br>generated by 2-point calibration and a master curve provided via the reagent<br>bar code. |
| 5.<br>Intended use | Immunoassay for the in vitro quantitative determination of carcinoembryonic<br>antigen (CEA) in human serum and plasma. The Elecsys CEA assay if further<br>indicated for serial measurement of CEA to aid in the management of cancer<br>patients.<br>The electrochemiluminescence immunoassay “ECLIA” is intended for use on<br>the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.<br>Summary |

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### 510(k) Summary, Continued

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#### 6. Comparison to predicate device

The Boehringer Mannheim Elecsys® CEA Assay has been approved for use on the Elecsys 2010 immunoassay analyzer (K964368). The application of the Elecsys® CEA Assay on the Elecsys 1010 immunoassay analyzer is substantially equivalent to the same assay (Elecsys CEA Assay) on the Elecsys 2010.

The following table compares the Elecsys® CEA Assay on Elecsys® 1010 with the predicate device, Elecsys® CEA Assay on Elecsys® 2010 . Specific data on the performance of this test for both the Elecsys 1010 and 2010 have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in attachment 6 will be replaced upon the clearance of this premarket notification submission with the combined Elecsys 2010 and 1010 insert (attachment 5).

#### Similarities:

•Intended Use: Immunoassay for the in vitro quantitative determination of Carcinoembryonic Antigen (CEA). The assay is further indicated for the serial measurement of CEA to aid in the management of cancer patients.

- ·Assay range: 0-1000 ng/mL
- · Assay methodology: Sandwich immunoassay
- ·Kit (cat. No.) also cleared for use on the Elecsys 2010 (K964368 )

·Sample and reagent volumes

·Package insert

- ·Performance specifications

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### 510(k) Summary, Continued

6.

Differences:

Comparison to predicate device cont.

| Feature | Elecsys® 1010 | Elecsys® 2010 |
|--------------------------------|---------------------|---------------|
| Instrument<br>required | Elecsys 1010 | Elecsys 2010 |
| Instrument<br>Type | Batch | Random access |
| Reagent<br>Storage Temp<br>(C) | Ambient Temperature | 20° C |

#### Performance Characteristics:

| Feature | Elecsys® 1010 | | Elecsys® 2010 | | |
|------------|-------------------------|-----------|-------------------------|-----------|--------|
| Precision | Modified NCCLS (ng/mL): | | Modified NCCLS (ng/mL): | | |
| Level | Control 1 | Control 2 | Control 1 | Control 2 | Pool 1 |
| N | 60 | 60 | 60 | 60 | 60 |
| Within-Run | 4.44 | 32.96 | 4.9 | 34.1 | 2.2 |
| %CV | 2.36 | 1.71 | 2.5 | 1.7 | 5.0 |
| Total | 4.44 | 35.51 | 4.9 | 34.1 | 2.2 |
| %CV | 3.07 | 2.09 | 3.6 | 3.0 | 5.4 |
| | Modified NCCLS (ng/mL): | | Modified NCCLS (ng/mL): | | |
| | Pool 2 | Pool 3 | Pool 2 | Pool 3 | |
| N | 60 | 60 | 60 | 60 | |
| Within-Run | 11.86 | 113.64 | 19.6 | 528 | |
| %CV | 1.57 | 2.89 | 1.6 | 1.3 | |
| Total | 11.86 | 113.64 | 19.6 | 528 | |
| %CV | 2.83 | 3.97 | 2.3 | 2.0 | |

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### 510(k) Summary, Continued

1. September 2017

| Performance Characteristics: | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Feature | Elecsys® 1010 | Elecsys® 2010 |
| Lower<br>Detection Limit | 0.2 ng/mL | 0.2 ng/mL |
| Linearity | 0.2 - 1000 ng/mL (with a<br>deviation from a linear line of<br>±10%) | 0.2 - 1000 ng/mL (with a<br>deviation from a linear line of<br>±10%) |
| Method<br>Comparison | Vs Elecsys 2010<br><br>Least Squares<br>$y=1.006x - 0.64$<br>$r=0.995$<br>$N=117$<br><br>Passing/Bablok<br>$y=0.958x + 0.14$<br>$r=0.995$<br>$N=117$ | |
| Hook Effect | No Hook Effect up to<br>200,000 ng/mL CEA | No Hook Effect up to<br>200,000 ng/mL CEA |

# Performance Characteristics:

:

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Image /page/5/Picture/2 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

JUN 2 9 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Patricia M. Klimley Manager, Regulatory Affairs Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900

Re : K980887 / S1 Trade Name: Elecsys® CEA Assay Requlatory Class: II Product Code: DHX Dated: May 4, 1998 Received: May 5, 1998

Dear Ms. Klimley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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Paqe 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4588. advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/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

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### 510(k) Number (if known): K980887

Device Name: Elecsys® CEA Assay

**Intended use**

Intended use
Immunoassay for the in vitro quantitative determination of carcinoembryonic antigen in
the serial Immunoassay for the in vitro qualificant and is further indicated for serial
human serum and plasma. The Elecsys assement of capcer natients. measurement of CEA to aid in the management of cancer patients. The electrochemiluminescence immunoassay "ECLA" is intended for use on the
The electrochemiluminescence immunoassay "ECLA" is intended for use on the The electrochemiummescence Inindhoussay - 2 commentsay analyzers.
Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

Peter. Mapes

(Division Sign ()ft) 298868 Division and Division ! 510(x) Number -

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

OR

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)