ELECSYS AFP

K973351 · Boehringer Mannheim Corp. · LOJ · Nov 21, 1997 · Immunology

Device Facts

• Record ID: K973351
• Device Name: ELECSYS AFP
• Applicant: Boehringer Mannheim Corp.
• Product Code: LOJ · Immunology
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of α₁-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 immunoassay analyzers.

Device Story

Elecsys AFP is an in vitro diagnostic immunoassay for quantitative measurement of alpha-fetoprotein in human serum and plasma; used to aid management of patients with non-seminomatous germ cell tumors. Device utilizes electrochemiluminescence immunoassay (ECLIA) technology on Boehringer Mannheim Elecsys immunoassay analyzers. Principle: sandwich immunoassay; sample reacts with biotinylated monoclonal AFP-specific antibody and ruthenium-labeled monoclonal AFP-specific antibody; complex binds to streptavidin-coated microparticles. Microparticles captured magnetically on electrode surface; unbound substances removed via ProCell; voltage application induces chemiluminescent emission measured by photomultiplier. Results calculated via instrument-specific calibration curve using 2-point calibration and master curve from reagent bar code. Operated by laboratory personnel in clinical settings. Output provides quantitative AFP levels to assist clinicians in monitoring disease status.

Clinical Evidence

Performance evaluated through bench testing and clinical sample comparison. Bench studies included assay precision (NCCLS recommendations), lower detection limit, linearity, and interference testing (hemoglobin, biotin, triglyceride, lipemia, rheumatoid factor, and pharmaceutical compounds). Clinical validation included correlation studies with the predicate device using serum and plasma samples from serially monitored patients diagnosed and treated for testicular cancer.

Technological Characteristics

Electrochemiluminescence immunoassay (ECLIA) using ruthenium complex label and streptavidin-coated microparticles. Sandwich assay principle. Requires Boehringer Mannheim Elecsys immunoassay analyzers. Calibration via 2-point calibration and reagent bar code master curve. Measurement via photomultiplier detection of chemiluminescence induced by electrode voltage.

Indications for Use

Indicated for the in vitro quantitative determination of α₁-fetoprotein 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

• Enzymun-Test® AFP (P860044)

Submission Summary (Full Text)

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K973351

| <b>BOEHRINGER<br/>MANNHEIM<br/>CORPORATION</b> | |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |

| 1) Submitter name, address, contact | Boehringer Mannheim Corporation<br>2400 Bisso Lane<br>Concord, CA 94524-4117<br>[phone]<br><br>Contact Person: Patricia M. Klimley<br>Date Prepared: September 2, 1997 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: Elecsys® AFP<br>Common name: Alpha-Fetoprotein assay<br>Classification name: Alpha-Fetoprotein test kit for testicular cancer |
| 3) Predicate device | We claim substantial equivalence to the Enzymun-Test® AFP (P860044). |
| 4) Device Description | The Elecsys® test principle is based on the sandwich principle. Total duration of assay: 18 minutes. <ul><li>1st incubation: 15 µl of sample, a biotinylated monoclonal AFP-specific antibody and a monoclonal AFP-specific antibody labeled with a ruthenium complex react to form a sandwich complex.</li><li>2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.</li></ul> |

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## 510(k) Summary, Continued

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| | <b>4) Device Description, cont.</b> | The reaction mixture is aspirated into the measuring cell where the micro- particles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. Results are determined via a calibration curve which is instrument- specifically generated by 2-point calibration and a master curve provided via the reagent bar code. |
|--|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <b>5) Intended use</b> | Immunoassay for the in vitro quantitative determination of α₁-fetoprotein in human serum and plasma to aid in the management of patients with non- seminomatous germ cell tumors. |
| | <b>6) Comparison to predicate device</b> | The Boehringer Mannheim Elecsys AFP is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun-Test AFP.<br>Studies performed include: evaluation of assay precision according to NCCLS recommendations determination of the lower detection limit demonstration of linearity correlation with the predicate device evaluation of the effect of various endogenous substances (hemoglobin, biotin, triglyceride, lipemia, and rheumatoid factor), and commonly used pharmaceutical compounds and serum plasma sample comparisons. determination of hook effect, and stability studies. In addition, comparisons of the Elecsys AFP and the predicate device were performed with samples from serially monitored patients diagnosed and treated for testicular cancer. |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 1 1997

Ms. Patricia M. Klimley Manager, Requlatory Affairs Boehringer Mannheim Corporation 2400 Bisso Lane Concord, California 94524-4117

Re: K973351 Trade Name: Elecsys® AFP Regulatory Class: II Product Code: LOJ Dated: September 2, 1997 September 5, 1997 Received:

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 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.

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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 Putman

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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K973351

510(k) Number (if known): Device Name: Elecsys® AFP Indications for Use:

Immunoassay for the in vitro quantitative determination of &;-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 immunoassay analyzers.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use*_*_

(Optional Format 1-2-96)