ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY

K031606 · Beckman Coulter, Inc. · LFX · Jun 20, 2003 · Microbiology

Device Facts

• Record ID: K031606
• Device Name: ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY
• Applicant: Beckman Coulter, Inc.
• Product Code: LFX · Microbiology
• Decision Date: Jun 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Intended Use

The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.

Device Story

Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay; detects IgG antibodies to rubella virus in human serum. Used on Beckman Coulter Access Immunoassay Systems (including UniCel Dxl 800). Reagents, calibrators, and QC are processed by the automated system to provide qualitative and quantitative results. Used in clinical laboratory settings by trained personnel. Output assists healthcare providers in diagnosing rubella infection and assessing patient immunity status.

Clinical Evidence

Bench testing only. Studies included reproducibility, concordance, and linearity. Method comparison using clinical data demonstrated good correlation between the Dxl and Access 2 systems via linear regression.

Technological Characteristics

Paramagnetic-particle, chemiluminescent immunoassay. Components: reagent packs, calibrators, QC, substrate, wash buffer. Platform: Access Immunoassay Systems (automated).

Indications for Use

Indicated for qualitative and quantitative determination of IgG antibodies to rubella virus in human serum to aid in diagnosis of rubella infection and determination of immunity.

Regulatory Classification

Identification

Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards': (i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,” (ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,” (iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,” (iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and (v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,” (2) Centers for Disease Control's: (i) Low Titer Rubella Standard, (ii) Reference Panel of Well Characterized Rubella Sera, and (3) World Health Organization's International Rubella Standard.

Predicate Devices

• Access Rubella IgG Assay for use on the Access Immunoassay Systems (K954687)

Reference Devices

• Beckman Coulter UniCel Dxl 800 Access Immunoassay System (K023764)

Submission Summary (Full Text)

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#### 1.5 510(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.

KO3160 510(k) Number _

Date Prepared: May 21,2003

| 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 Rubella IgG Assay |
|-----------------------------------------|-------------------------------------------------------------------------------------------------|
| Classification Name | Rubella virus serological reagents |
| Device Class | Class II |
| Legally Marketed (Unmodified)<br>Device | Access Rubella IgG Assay for use on the Access Immunoassay<br>Systems (K954687, cleared 4/6/96) |

### Device Description

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

### Intended Use

The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.

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## 510(k) Summary

# Description of the Modification to the Legally Marketed Device

The modification to the Access Rubella 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 Dxl System was cleared for marketing by FDA on January 28, 2003, (K023764).

The DxI uses the same Access Rubella 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 Rubella 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 Rubella IgG assay on the Dxl System is substantially equivalent to the Access Rubella IgG assay on the Access 2 System, reproducibility, concordance and linearity studies were conducted. The Access Rubella IqG assay met the established acceptance criteria for reproducibility and concordance and demonstrated acceptable linearity. A method comparison (linear regression) study completed using clinical 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 Rubella IgG Assay on the UniCel Dxl 800 Access Immunoassay System.

# (Page 2 of 2)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

JUN 2 0 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: k031606

Trade/Device Name: Access Rubella IgG Assay for use on the Access® Immunoassay System Regulation Number: 21 CFR 866.3510 Regulation Name: Rubella Virus Serological Reagents Regulatory Class: Class II Product Code: LFX Dated: May 21, 2003 Received: May 22, 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. 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 (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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#### 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 Putman

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 1.4

510(k) Number (if known): 长۵3 (66 PAGE 1 OF 1

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

Indications for Use:

The Access Rubella IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the using the Access Immunoassay Systems. The Access Rubella IgG assay aids in the diagnosis of rubella infection and the determination of immunity.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (per 21 CFR 801.109) | <span style="text-decoration: overline;">✓</span> |
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OR

| Over-the-Counter Use (Optional Format 1-2-96) | ____________________ |
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Office of In Vitro Diagnostic DeviceEvaluation and Safety

510(k) K031606