(181 days)
Abbott IMx Rubella IgG
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No
The summary describes a standard immunoassay system and does not mention any AI or ML components.
No
This device is an immunoassay for diagnosing Rubella infection and determining immunity, which falls under diagnostic purposes, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "aids in the diagnosis of Rubella infection."
No
The device description explicitly states it is a paramagnetic-particle, chemiluminescent immunoassay using the ACCESS® Immunoassay System, indicating it is a hardware-based assay system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the assay "aids in the diagnosis of Rubella infection and the determination of immunity." This is a diagnostic purpose.
- Device Description: The description states it's an "immunoassay for the qualitative and quantitative determination of IgG antibodies to the Rubella virus in human serum." This involves testing a biological sample (human serum) in vitro (outside the body) to gain information about a person's health status (presence of antibodies indicating infection or immunity).
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACCESS® Rubella IgG assay aids in the diagnosis of Rubella infection and the determination of immunity.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
In clinical studies, the ACCESS® Rubella IgG was compared to HAI on 784 patient serum samples. A comparison to the Abbott IMx Rubella IgG was done on 670 patient serum samples.
Key Metrics
relative sensitivity and specificity were 98% and 99%, respectively.
The concordance was 90%.
Representative data for 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.
Predicate Device(s)
Abbott IMx Rubella IgG
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3510 Rubella virus serological reagents.
(a)
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).(b)
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.
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SANOFI DIAGNOSTICS PASTEUR, INC. 1000 LAKE HAZELTINE DRIVE CHASKA, MINNESOTA 55318-1084 U.S.A. TEL: (612) 448-4848
APR - 9 1996
Image /page/0/Picture/3 description: The image shows a logo for Sanofi Pasteur Diagnostics. The logo is in a rectangular box with the word "Sanofi" in large, bold, white letters on a black background. Below that, the word "Pasteur" is in large, bold, white letters on a black background, with the word "Diagnostics" in smaller letters above it. The logo is simple and modern, and it is likely used to identify the company's products or services.
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 Hazelline 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 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.