ACCESS RUBELLA IGG

K954687 · Bio-Rad Laboratories, Inc. · LFX · Apr 9, 1996 · Microbiology

Device Facts

• Record ID: K954687
• Device Name: ACCESS RUBELLA IGG
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: LFX · Microbiology
• Decision Date: Apr 9, 1996
• Decision: SESE
• Submission Type: Traditional
• 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 ACCESS® Immunoassay System. The ACCESS® Rubella IgG assay aids in the diagnosis of Rubella infection and the determination of immunity.

Device Story

Paramagnetic-particle, chemiluminescent immunoassay; utilizes ACCESS® Immunoassay System; processes human serum samples; detects IgG antibodies to Rubella virus. Used in clinical laboratory settings by trained personnel. Output provides qualitative/quantitative antibody levels; aids clinicians in diagnosing Rubella infection and assessing patient immunity status.

Clinical Evidence

Clinical study on 784 patient serum samples vs HAI: 98% relative sensitivity, 99% relative specificity. Comparison to Abbott IMx on 670 samples: 90% concordance. Precision studies (within-run, within-site, total) reported CVs ranging from 6% to 16% across negative, low reactive, and high positive controls.

Technological Characteristics

Paramagnetic-particle, chemiluminescent immunoassay. Designed for use on the ACCESS® Immunoassay System. Analyte: Rubella IgG antibodies. Sample matrix: human serum.

Indications for Use

Indicated for the qualitative and quantitative determination of IgG antibodies to Rubella virus in human serum to aid in the diagnosis of Rubella infection and determination of immune status.

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

• Abbott IMx Rubella IgG

Reference Devices

• HAI (Hemagglutination Inhibition assay)

Submission Summary (Full Text)

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SANOFI DIAGNOSTICS PASTEUR, INC.
1000 LAKE HAZELTINE DRIVE
CHASKA, MINNESOTA 55318-1084 U.S.A.
TEL: [phone]
K954687
APR - 9 1996
sanofi Pasteur

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

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

## 1. General Information

Device Classification Name: Rubella Virus Serological Reagents
Device Trade Name: ACCESS® Rubella IgG Reagents
Applicant's Name and Address: Sanofi Diagnostics Pasteur, Inc.
1000 Lake Hazeltine Drive
Chaska, MN 55318

## 2. Predicate Device

Abbott IMx Rubella IgG
Abbott Laboratories
Diagnostics Division
Abbott Park, IL 60064

## 3. Device Description

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 ACCESS® Immunoassay System. The ACCESS® Rubella IgG assay aids in the diagnosis of Rubella infection and the determination of immunity.

## 4. Summary of Studies

In clinical studies, the ACCESS® Rubella IgG was compared to HAI on 784 patient serum samples. The relative sensitivity and specificity were 98% and 99%, respectively.

A comparison to the Abbott IMx Rubella IgG was done on 670 patient serum samples. The concordance was 90%.

Representative data for within run, within site and total precision are 15%, 15% and 16% for the QC1 negative control, 6%, 6% and 6% for the QC2 low reactive control, and 9%, 11% and 12% for a high positive sample.

## 5. Conclusion

The Sanofi Diagnostics Pasteur ACCESS Rubella IgG is substantially equivalent to a standard laboratory reference method (HAI) and to another kit currently in commercial distribution for the determination of IgG antibodies to Rubella in human serum samples.

Kallestad
GeneticSystems
DIAGNOSTICS Pasteur