ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY

K031506 · Beckman Coulter, Inc. · LGD · Jun 2, 2003 · Microbiology

Device Facts

• Record ID: K031506
• Device Name: ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
• Applicant: Beckman Coulter, Inc.
• Product Code: LGD · Microbiology
• Decision Date: Jun 2, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3780
• Device Class: Class 2

Intended Use

The Access Toxo IgM II assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative determination of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma, using the Access Immunoassay Systems. The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay.

Device Story

The Access Toxo IgM II assay is a paramagnetic-particle, chemiluminescent immunoassay used to detect T. gondii-specific IgM antibodies in human serum and plasma. The assay is performed on Beckman Coulter Access Immunoassay Systems, including the UniCel Dxl 800. The system processes samples to produce qualitative results, which are used by clinicians to aid in the diagnosis of acute, recent, or reactivated toxoplasmosis. The assay is intended for use in conjunction with IgG antibody testing. The device is operated by laboratory personnel in a clinical setting. Results assist healthcare providers in clinical decision-making regarding infection status, potentially benefiting patients by facilitating timely diagnosis and management of T. gondii infections.

Clinical Evidence

Bench testing only. Reproducibility and concordance studies were conducted to compare the performance of the Access Toxo IgM II assay on the UniCel Dxl 800 system versus the Access 2 system. Method comparison using linear regression analysis demonstrated good correlation between the two platforms, meeting established acceptance criteria.

Technological Characteristics

Paramagnetic-particle, chemiluminescent immunoassay. Components include reagent packs, controls, QC, substrate, and wash buffer. System is an automated immunoassay analyzer. Connectivity is via the Access Immunoassay System platform.

Indications for Use

Indicated for qualitative determination of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma. Used for presumptive diagnosis of acute, recent, or reactivated T. gondii infection in males and pregnant or non-pregnant females. Recommended for use with T. gondii-specific IgG antibody assay.

Regulatory Classification

Identification

Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.

Predicate Devices

• Access Toxo IgM II Reagents for use on the Access Immunoassay System (K003259)

Reference Devices

• UniCel Dxl 800 Access Immunoassay System (K023764)

Submission Summary (Full Text)

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

031506

1.4 510(K) Summary

(Page 1 of 2)

Confidential

## 510(k) Summary

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

### 510(k) Number

Date Prepared: May 13,2003

| Submitter | Contact Person |
|---------------------------|-------------------------------------|
| Beckman Coulter, Inc | Lynn Weist |
| 1000 Lake Hazeltine Drive | Staff Regulatory Affairs Specialist |
| Chaska, MN 55318 | Phone: [phone] |
| | Fax: [phone] |

### General Information

| Proprietary Name | Access® Immunoassay System Toxo IgM II Assay |
|--------------------------------------|----------------------------------------------------------------------------------------------------|
| Classification Name | Toxoplasma gondii serological reagents |
| Device Class | Class II |
| Legally Marketed (Unmodified) Device | Access Toxo IgM II Reagents for use on the Access<br>Immunoassay System (K003259, cleared 6/13/01) |

## Device Description

The Access Toxo IgM II reagents consist of reagent packs, controls, QC, substrate and wash buffer.

## Intended Use

The Access Toxo IgM II assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative determination of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma, using the Access Immunoassay Systems. The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay.

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

Beckman Coulter, Inc.

# Description of the Modification to the Legally Marketed Device

The modification to the Access Toxo IgM II reagents is to add a new instrument platform, the Beckman Coulter UniCel" Dxl 800 Access® Immunoassay System, to the family of Access Immunoassay Systems. The Dxl System is a new model within the same model series of Access Immunoassay Systems manufactured and distributed by Beckman Coulter, Inc. The Dxl System was cleared for marketing by FDA on January 28, 2003, (K023764).

The DxI uses the same Access Toxo IgM II reagents, controls and QC, packaged the same as for the Access 2 System. The formulations of the substrate and wash buffer used with the Access Toxo IgM II assay are unchanged. There are no changes to the intended uses, technical specifications or final performance specifications and claims for the assay.

# Supporting Data

In order to demonstrate that the Access Toxo IgM II assay on the Dxl System is substantially equivalent to the Access Toxo IgM II assay on the Access 2 System, reproducibility and concordance studies were conducted. The Access Toxo IgM II assay met the established acceptance criteria for reproducibility and concordance. Method comparison (linear regression) using the concordance study data was completed and showed good correlation between the Dxl and Access 2 Systems.

# Conclusion

The information provided in this submission supports a substantial equivalence determination, and therefore, 510(k) premarket notification clearance of the Access Toxo IgM II Reagents on the UniCel Dxl 800 Access Immunoassay System.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.

JUN - 2 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lynn Weist Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

k031506 Re:

Trade/Device Name: Access Toxo IgM II Reagents for use on the Access Immunoassay Systems Regulation Number: 21 CFR 866.3780 Regulation Name: Toxoplasma Gondii Serological Reagents Regulatory Class: Class II Product Code: LGD Dated: May 13, 2003 Received: May 14, 2003

Dear Ms. Weist:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

#### Page 2 -

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 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 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 Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

#### 1.3 Indications for Use Statement

510(k) Number (if known):_K D 3 15 b PAGE 1 OF 1

Device Name: Access® Toxo IgM II Reagents for use on the Access® Immunoassay Systems

Indications for Use:

The Access Toxo IgM II assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative determination of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma, using the Access Immunoassay Systems. The Access Toxo IgM II assay is presumptive for the diagnosis of acute, recent, or reactivated Toxoplasma gondii infections in males and pregnant or non-pregnant females. It is recommended this assay be performed in conjunction with a Toxoplasma gondii-specific IgG antibody assay.

(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) | <div> <span style="font-size: 2em;">✓</span> </div> | OR | Over-the-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|-----------------------------------------------------|----|--------------------------------------------------|
|------------------------------------------|-----------------------------------------------------|----|--------------------------------------------------|

Freddie lu. Cook

Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and SafetyKO 31506

510(k).