← Product Code [LFX](/submissions/MI/subpart-d%E2%80%94serological-reagents/LFX) · K954687 # ACCESS RUBELLA IGG (K954687) _Bio-Rad Laboratories, Inc. · LFX · Apr 9, 1996 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFX/K954687 ## Device Facts - **Applicant:** Bio-Rad Laboratories, Inc. - **Product Code:** [LFX](/submissions/MI/subpart-d%E2%80%94serological-reagents/LFX.md) - **Decision Date:** Apr 9, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3510 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## 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 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SANOFI DIAGNOSTICS PASTEUR, INC. 1000 LAKE HAZELTINE DRIVE CHASKA, MINNESOTA 55318-1084 U.S.A. TEL: (612) 448-4848 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 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFX/K954687](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LFX/K954687) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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