FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020

K052082 · Beckman Coulter, Inc. · JMG · Aug 19, 2005 · Immunology

Device Facts

• Record ID: K052082
• Device Name: FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
• Applicant: Beckman Coulter, Inc.
• Product Code: JMG · Immunology
• Decision Date: Aug 19, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The Beckman Coulter Ferritin assay is an in vitro diagnostic test for the quantitative determination of ferritin in human serum and plasma using the Access Immunoassay Systems. Ferritin measurements are used in the diagnosis and management of diseases involving iron metabolism such as hemochromatosis and iron deficiency anemia.

Device Story

Automated immunoassay system for ferritin quantification in serum/plasma; utilizes Access Immunoassay Analyzers (Access, Access 2, SYNCHRON LXi 725, UniCel Dxl 800). Modification adds auto-dilution feature (1:10 ratio using Access Wash Buffer) to extend reportable range to 1300–15,000 ng/mL; includes automated mixing step in dilution vessel. Protocol modification ensures main pipettor depth adjustment for improved reagent mixing/aspiration. Operated by laboratory personnel in clinical settings. Output provides quantitative ferritin levels to clinicians for iron metabolism assessment and disease management.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm performance of auto-dilution feature and pipettor depth adjustments. Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Two-site immunoenzymatic (sandwich) assay. Solid phase: paramagnetic particles coated with goat anti-mouse IgG. Conjugate: goat anti-ferritin-alkaline phosphatase. System includes automated dilution feature (1:10) and updated pipettor depth control via assay protocol file. Operates on Access Immunoassay Systems (Access, Access 2, SYNCHRON LXi 725, UniCel DxI 800).

Indications for Use

Indicated for the quantitative determination of ferritin levels in human serum and plasma (heparin) using Access Immunoassay Systems. For prescription use only.

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

• Beckman Coulter Ferritin on the Access® Immunoassay Systems (K926221)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a black circle with two curved white lines inside. The text "BECKMAN" is on the top line and "COULTER" is on the bottom line.

AUG 1 9 2005

#### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in This Summary of Creek) in the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

K052082

## Submitter's Name and Address

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: [phone] Fax: [phone] Contact: Carolyn Anderson

Date Prepared: August 1, 2005

#### Device Names

Ferritin on the Access® Immunoassay Systems Proprietary Name:

Ferritin test system Common Name:

Classification Name: Enzyme Immunoassay, Ferritin

#### Predicate Device

Access Ferritin Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

510(k) Number: K926221

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

#### Device Description

The Access Ferritin reagents, Access Ferritin Calibrators and the Access The - Access - Land - Saless 2, Synchron LX® 725, and UniCel DxI™ 800) comprise the Access Immunoassay Systems for the quantitative determination of ferritin levels in human serum and plasma (heparin).

#### Intended Use

The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

| Attribute | Access Ferritin Assay | Access Ferritin Assay<br>(modified) |
|--------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Methodology | Two site immunoenzymatic<br>(sandwich) assay | Two site immunoenzymatic<br>(sandwich) assay |
| Intended Use | Quantitative determination<br>of ferritin levels in human<br>serum and plasma<br>(heparin) | Quantitative determination<br>of ferritin levels in human<br>serum and plasma<br>(heparin) |
| Solid Phase | Paramagnetic particles<br>coated with goat anti-<br>mouse IgG | Paramagnetic particles<br>coated with goat anti-<br>mouse IgG |
| Conjugate | Goat anti-ferritin-alkaline<br>conjugate | Goat anti-ferritin-alkaline<br>conjugate |
| Calibrators | Human liver ferritin at<br>levels of 0 and<br>approximately 10, 50, 200,<br>500, and 1500 ng/mL<br>(µg/L) | Human liver ferritin at<br>levels of 0 and<br>approximately 10, 50, 200,<br>500, and 1500 ng/mL<br>(µg/L) |

## Comparison of Technological Characteristics

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

## Summary of Technological Characteristics

The device modification consists of the addition of an auto-dilution feature that allows a 1:10 on-board system dilution of human serum and plasma (heparin) anove a The auto-dilution feature is intended for all Access Immunoassay Analyzers (Access, Access 2, SYNCHRON® LXi 725, and UniCel® Dxl 800) and requires a change to the assay-specific software, referred to as the assay protocol file, for each member of this instrument family. The change does not affect assay performance characteristics.

A modification to the assay protocol file (APF) to ensure the main pipettor drops to a sufficient depth in the reagent pack when transferring material from the particle well and the conjugate well is being made to improve particle mixing and to ensure sufficient aspiration of reagents for transfer to the reaction vessel. This modification is being made for both the Ferritin and the auto-dilution (Dil-Ferritin) assays.

The Access Wash Buffer is currently used as the system buffer in the Access Ferritin assay on all Access Immunoassay Analyzers. The labeling is affected in that the directional insert has been revised to describe the addition of the autodilution feature. No changes have been made to the Access, Access 2, SYNCHRON® LXi 725, or UniCel® Dxl 800 system software or hardware. The changes do not affect assay reaction kinetics. No changes have been made to the Access Ferritin assay reagents, calibrators or sample diluent. Access Wash Buffer is used to perform the auto-dilution.

## Conclusion

The modified Access Ferritin on the Access Immunoassay Systems including onboard auto-dilutions is substantially equivalent to the Access Ferritin assay for the quantitative determination of ferritin levels in human serum and plasma (heparin).

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

## l. continued...

:

:

#### Indications for Use Statement c.

The indications for use statement appears on the following page.

:

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

Public Health Service

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to promoting health, well-being, and human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)", which is arranged in a circular fashion around the left side of the logo.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Beckman Coulter, Inc. c/o Ms Carolyn Anderson Sr. Regulatory Affairs Specialist 1000 Lake Hazeltine Dr. Chaska, MN 55318-1084

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Trade/Device Name: Ferritin on the Access® Immunoassay Systems Regulation Number: 21 CFR 866.5340 Regulation Name: Ferritin immunological test system Regulatory Class: Class II Product Code: JMG Dated: August 1, 2005 Received: August 2, 2005

Dear Ms. Anderson:

Re: k052082

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in also 1976, the enactment date of the Medical Device Amendments, or to devices that provision thay 20, 1970, and cordance 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 therefore, maniovate as as as act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

AUG 1 9 2005

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it r your averies to such additional controls. Existing major regulations affecting your device can be fray of babyer 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

{5}------------------------------------------------

Page 2 -

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In of the Diagnostic Device Evaluation and Safety at [phone]. Also, please note the Vitto Diagnosto D'ONeo Danding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I vi inay oodin only generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PK.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

# Indications for Use Statement

510(k) Number (if known):

Kos2082

Device Name: Access Ferritin on the Access® Immunoassay Systems

Indications For Use:

The Access Ferritin assay is a paramagnetic particle, chemiluminescent The Access - Forman - accept - of its - determination of ferritin levels in human serum immunodouly 16. In the using the Access Immunoassay Systems.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

ستعمنهائ متربود بربر

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mana c. Lan

Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_ KO52082