ELECSYS FERRITIN

K971833 · Boehringer Mannheim Corp. · JMG · Jun 2, 1997 · Immunology

Device Facts

• Record ID: K971833
• Device Name: ELECSYS FERRITIN
• Applicant: Boehringer Mannheim Corp.
• Product Code: JMG · Immunology
• Decision Date: Jun 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of ferritin in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" us intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

Device Story

Elecsys Ferritin is an in vitro diagnostic immunoassay for quantitative ferritin measurement in human serum and plasma. It utilizes a sandwich test principle: sample incubation with biotinylated monoclonal ferritin-specific antibody and ruthenium-labeled monoclonal ferritin-specific antibody; subsequent binding to streptavidin-coated microparticles. The reaction mixture is aspirated into a measuring cell where microparticles are magnetically captured on an electrode surface. Application of voltage induces chemiluminescent emission, measured by a photomultiplier. The device is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer in a clinical laboratory setting. Results are calculated via a calibration curve generated by 2-point calibration and a master curve provided via reagent bar code. The assay provides clinicians with quantitative ferritin levels to aid in the assessment of iron status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sandwich immunoassay; electrochemiluminescence detection; streptavidin-coated microparticles; biotinylated monoclonal antibodies; ruthenium complex label. Operates on the Elecsys 2010 immunoassay analyzer. Calibration via 2-point method and master curve provided by reagent bar code.

Indications for Use

Indicated for the in vitro quantitative determination of ferritin in human serum and plasma for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

Regulatory Classification

Identification

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

Predicate Devices

• Enzymun-Test® Ferritin

Submission Summary (Full Text)

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K971833

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## 510(k) Summary

# JUN – 2 1997

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| 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 9115 Hague Rd. Indianapolis, IN 46250 [phone] |
| | Contact Person: LeeAnn Chambers |
| | Date Prepared: May 15, 1997 |
| 2) Device name | Proprietary name: Elecsys® Ferritin |
| | Common name: Ferritin immunological test system |
| | Classification name: Ferritin immunological test system |
| 3) Predicate device | We claim substantial equivalence to Enzymun-Test® Ferritin. |
| 4) Device Description | The Elecsys® Ferritin employs a sandwich test principle with monoclonal antibodies directed against ferritin and with streptavidin microparticles and electrochemiluminescence detection. |
| | Total duration of assay: 18 minutes. |
| | • 1st Incubation: 15 µl of sample a biotinylated monoclonal ferritin-specific antibody and a monoclonal ferritin-specific antibody labeled with a ruthenium complex react to form a sandwich complex. |
| | • 2nd Incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. |
| | Continued on next page |

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### 510(k) Summary, Continued

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Comments of Children Children

| 4) Device<br>Description | • 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<br>voltage to the electrode then induces chemiluminescent emission which is<br>measured by a photomultiplier.<br>• Results are determined via a calibration curve which is instrument-<br>specifically generated by 2-point calibration and a master curve provided<br>via the reagent bar code. |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5) Intended use | Immunoassay for the in vitro quantitative determination of ferritin in human<br>serum and plasma. |
| 6) Comparison<br>` to predicate<br>device | The Boehringer Mannheim Elecsys Ferritin is substantially equivalent to<br>other products in commercial distribution intended for similar use. Most<br>notably it is substantially equivalent to the currently marketed Enzymun-Test<br>Ferritin. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. LeeAnn Chambers, RAC Program Manager, Regulatory Affairs Boehringer Mannheim Corporation Regulatory Affairs Quality System and Compliance 9115 Hague Road Indianapolis, Indiana 46250

Re: K971833 Trade Name: Elecsys® Ferritin Regulatory Class: II Product Code: JMG Dated: May 15, 1997 Received: May 19, 1997

Dear Ms. Chambers:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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.

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].

UN - 2 1997

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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 yitto 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 Sutman

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): Device Name: Elecsys® Ferritin Indications for Use:

Immunoassay for the in vitro quantitative determination of ferritin in human serum and plasma. The electrochemiluminescence immunoassay "ECLIA" us intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

Peter E. Madini

**Division Sign-Off**
**Division of Clinical Laboratory Devices**
**510(k) Number**

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)