ELECSYS AFP

K981282 · Roche Diagnostics GmbH · LOJ · May 1, 1998 · Immunology

Device Facts

• Record ID: K981282
• Device Name: ELECSYS AFP
• Applicant: Roche Diagnostics GmbH
• Product Code: LOJ · Immunology
• Decision Date: May 1, 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 alpha-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

Device Story

Elecsys AFP Assay is an in vitro diagnostic immunoassay for quantitative AFP measurement in human serum/plasma. It utilizes electrochemiluminescence (ECLIA) sandwich principle. Input: 30 µL sample, biotinylated monoclonal AFP-specific antibody, and ruthenium-labeled monoclonal AFP-specific antibody. Process: 1st incubation forms sandwich complex; 2nd incubation binds complex to streptavidin-coated microparticles. Mixture aspirated into measuring cell; microparticles magnetically captured on electrode. Unbound substances removed via ProCell. Voltage application induces chemiluminescent emission measured by photomultiplier. Results calculated via instrument-specific calibration curve (2-point calibration + master curve from reagent bar code). Used in clinical laboratories on Elecsys 1010/2010 analyzers. Output: AFP concentration (IU/mL). Assists clinicians in monitoring non-seminomatous germ cell tumor patients.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (N=60 per level), linearity (0.5-1000 IU/mL), and method comparison against the predicate Elecsys 2010 (N=153). Method comparison showed high correlation (r=0.992) using both Least Squares (y=0.980x+0.639) and Passing/Bablok (y=1.031x-0.208) regression. No hook effect observed up to 1,000,000 IU/mL.

Technological Characteristics

Sandwich immunoassay using electrochemiluminescence (ECLIA). Reagents: biotinylated monoclonal AFP-specific antibody, ruthenium-labeled monoclonal AFP-specific antibody, streptavidin-coated microparticles. Detection: photomultiplier tube measuring chemiluminescent emission upon voltage application. Connectivity: reagent bar code for master curve input. System: Elecsys 1010 analyzer (batch processing).

Indications for Use

Indicated for the in vitro quantitative determination of alpha-fetoprotein (AFP) in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors.

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 AFP on Elecsys 2010 (K973351)

Submission Summary (Full Text)

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a

K981282

| MAY 1 1998 | 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,<br>address,<br>contact | Roche Diagnostics/Boehringer Mannheim Corporation<br>4300 Hacienda Drive<br>P.O. Box 9002<br>Pleasanton, CA 94566-0900<br>[phone] |
| | Contact Person: Patricia M. Klimley<br>Date Prepared: April 6, 1998 |
| 2.<br>Device name | Proprietary name: Elecsys® AFP Assay<br>Common name: Electrochemiluminescence assay for the determination of<br>Alpha Fetoprotein (AFP). |
| | Classification name: Kit, Test , Alpha Fetoprotein |
| 3.<br>Predicate<br>device | The Roche Diagnostics/Boehringer Mannheim Elecsys® AFP on Elecsys®<br>1010 is substantially equivalent to other products in commercial distribution<br>intended for similar use. Most notably it is substantially equivalent to the<br>currently marketed Elecsys® AFP 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 µL), biotinylated monoclonal AFP-<br>specific antibody (60 µL), and a monoclonal AFP-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 µL), the complex is bound to the solid phase via interaction<br>of biotin and streptavidin. |
| <b>4.</b><br><b>Device</b><br><b>Description</b> | •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<br>by a photomultiplier (0.4 second read frame).<br>•Results are determined via a calibration curve which is instrument-<br>specifically generated by 2-point calibration and a master curve provided via<br>the reagent bar code. |
| <b>5.</b><br><b>Intended use</b> | Immunoassay for the in vitro quantitative determination of alpha fetoprotein<br>(AFP) in human serum and plasma.<br>The electrochemiluminescence immunoassay “ECLIA” is intended for use on<br>the Roche Diagnostics/Boehringer Mannheim Elecsys 1010 and 2010<br>immunoassay analyzers. |
| <b>6.</b><br><b>Comparison</b><br><b>to predicate</b><br><b>device</b> | The Roche Diagnostics/Boehringer Mannheim Elecsys® AFP Assay has been<br>approved for use on the Elecsys 2010 immunoassay analyzer (K973351).<br>The application of the Elecsys® AFP Assay on the Elecsys 1010<br>immunoassay analyzer is substantially equivalent to the same assay (Elecsys<br>AFP Assay) on the Elecsys 2010. |

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## 510(k) Summary, Continued

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The following table compares the Elecsys® AFP Assay on Elecsys® 1010 with the predicate device, Elecsys® AFP 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 Alpha Fetoprotein (AFP). The assay is further indicated for the serial measurement of AFP to aid in the management of cancer patients.

·Assay range: 0.5-1000 IU/mL

· Assay methodology: Sandwich immunoassay

·Kit (cat. No.) also cleared for use on the Elecsys 2010 (K973351 )

·Sample and reagent volumes

·Package insert

·Performance specifications

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## 510(k) Summary, Continued

6.

Comparison
to predicate device cont.

| Differences: |
|--------------|
|--------------|

| 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<br>Level | Modified NCCLS (IU/mL):<br>HS1 | Modified NCCLS (IU/mL):<br>HS2 | Modified NCCLS (IU/mL):<br>HS3 | Modified NCCLS (IU/mL):<br>HS1 | Modified NCCLS (IU/mL):<br>HS2 | Modified NCCLS (IU/mL):<br>HS3 | |
| N | 60 | 60 | 60 | 60 | 60 | 60 | |
| Within-Run | 9.81 | 50.67 | 607.39 | 12.8 | 42.6 | 566 | |
| %CV | 1.01 | 1.02 | 1.52 | 2.0 | 1.5 | 2.0 | |
| Total | 9.81 | 50.67 | 607.39 | 12.8 | 42.6 | 566 | |
| %CV | 2.25 | 2.69 | 4.61 | 3.1 | 2.4 | 2.8 | |
| | Modified NCCLS (IU/mL): | | | | Modified NCCLS (IU/mL): | | |
| | Control 1 | | Control 2 | | Control 1 | Control 2 | |
| N | 60 | | 60 | 60 | | 60 | |
| Within-Run | 7.72 | | 86.81 | 8.01 | | 86.8 | |
| %CV | 1.29 | | 1.39 | 2.8 | | 2.2 | |
| Total | 7.72 | | 86.81 | 8.01 | | 86.8 | |
| %CV | 1.90 | | 2.29 | 3.4 | | 2.7 | |

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# 510(k) Summary, Continued

| Feature | Elecsys® 1010 | Elecsys® 2010 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Lower<br>Detection Limit | 0.5 IU/mL | 0.5 IU/mL |
| Linearity | 0.5 - 1000 IU/mL (with a<br>deviation from a linear line of<br>±10%) | 0.5 - 1000 IU/mL (with a<br>deviation from a linear line of<br>±10%) |
| Method<br>Comparison | Vs Elecsys 2010<br><br>Least Squares<br>$y = 0.980x + 0.639$<br>r=0.992<br>N=153<br><br>Passing/Bablok<br>$y = 1.031x - 0.208$<br>r=0.992<br>N=153 | |
| Hook Effect | No Hook Effect up to<br>1,000,000 IU/mL AFP | No Hook Effect up to<br>1,000,000 IU/mL AFP |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.

#### MAY 10000

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

Re : K981282 Trade Name: Elecsys® AFP Assay Requlatory Class: II Product Code: LOJ Dated: April 6, 1998 Received: April 8, 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, qood manufacturing practice, labeling, and prohibitions aqainst 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 regulation may result in regulatory 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 Regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Page 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 labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and 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): 798 | 282

Device Name: Elecsys® AFP Assay

Indications For Use:

#

Immunoassay for the in vitro quantitative determination of alpha-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

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

| | | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
|------------------------------------------|--|--------------------------------------------------------|----|--------------------------|--|
| Prescription Use<br>(Per 21 CFR 801.109) | | | OR | Over-The-Counter Use | |
| | | | | (Optional Format 1-2-96) | |
| | | | | | |

Vita E. Mafeni

(Division Sign-Off)

Division of Climical Laboratory DJ 510(k) Nurtiber .