ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY

K032162 · Beckman Coulter, Inc. · LGD · Aug 8, 2003 · Microbiology

Device Facts

• Record ID: K032162
• Device Name: ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
• Applicant: Beckman Coulter, Inc.
• Product Code: LGD · Microbiology
• Decision Date: Aug 8, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3780
• Device Class: Class 2

Intended Use

The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum, using the Access Immunoassay Systems. The Access Toxo IgG assay aids in the diagnosis of Toxoplasma gondii infection and in the determination of protective levels of antibodies in pregnant women.

Device Story

The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay used to detect IgG antibodies to Toxoplasma gondii in human serum. The device utilizes reagent packs, calibrators, QC, substrate, and wash buffer. It is designed for use on Beckman Coulter Access Immunoassay Systems, including the UniCel Dxl 800. The system processes samples to provide qualitative and quantitative results, which are used by clinicians to diagnose infection and assess protective antibody levels in pregnant patients. The modification described involves expanding the platform compatibility to include the Dxl 800 system, maintaining the same reagents and performance specifications as the predicate.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance on the Dxl 800 Access Immunoassay System.

Technological Characteristics

Paramagnetic-particle, chemiluminescent immunoassay. Components include reagent packs, calibrators, QC, substrate, and wash buffer. System is an automated immunoassay analyzer (UniCel Dxl 800).

Indications for Use

Indicated for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum to aid in the diagnosis of infection and determination of protective antibody levels in pregnant women.

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 IgG Assay for use on the Access Immunoassay Systems (K951495)

Submission Summary (Full Text)

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#### 1.4 510(K) Summary

(Page 1 of 2)

## 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 K032162

Date Prepared: July 11, 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 IgG Assay |
|-----------------------------------------|------------------------------------------------------------------------------------------------|
| Classification Name | Toxoplasma gondii serological reagents |
| Device Class | Class II |
| Legally Marketed (Unmodified)<br>Device | Access Toxo IgG Assay for use on the Access Immunoassay<br>Systems (K951495, cleared 12/20/95) |

## Device Description

The Access Toxo IgG reagents consist of reagent packs, calibrators, QC, substrate and wash buffer.

## Intended Use

The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum, using the Access Immunoassay Systems. The Access Toxo IgG assay aids in the diagnosis of Toxoplasma gondii infection and in the determination of protective levels of antibodies in pregnant women.

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## 510(k) Summary

# (Page 2 of 2)

# Description of the Modification to the Legally Marketed Device

The modification to the Access Toxo IgG assay 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 DxI System was cleared for marketing by FDA on January 28, 2003, (K023764).

The DxI uses the same Access Toxo IgG reagents, Calibrators and QC, packaged the same as for the Access 2 System. The formulations of the substrate and wash buffer used with the Access Toxo IgG 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 IgG assay on the Dxl System is substantially equivalent to the Access Toxo IgG assay on the Access 2 System, reproducibility, concordance and linearity studies were conducted. The Access Toxo IgG assay met the established acceptance criteria for reproducibility and demonstrated acceptable concordance and linearity. A method comparison (linear regression) study completed using the concordance study data demonstrated good correlation between the DxI 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 IgG Assay on the UniCel Dxl 800 Access Immunoassay System.

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Public Health Service

AUG - 8 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

Re: k032162

> Trade/Device Name: Access Toxo IgG Assay 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: July 14, 2003 Received: July 15, 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 your 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).

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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

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#### Indications for Use Statement 1.3

510(k) Number (if known): K032162 PAGE 1 OF 1

Device Name: Access® Toxo IgG Assay for use on the Access® Immunoassay Systems

Indications for Use:

The Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum, using the Access Immunoassay Systems. The Access Toxo IgG assay aids in the diagnosis of Toxoplasma gondii infection and in the determination of protective levels of antibodies in pregnant women.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﻜ (per 21 CFR 801.109) OR

Over-the-Counter Use (Optional Format 1-2-96)

Sally Ann
Division Sign-Off 8/7/03

Office of In Vitro Diagnostic Device Evaluation and Safety

KB 3 21122 510(k)_