Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3510](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3510) → OMI — Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

# OMI · Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

_Microbiology · 21 CFR 866.3510 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OMI

## Overview

- **Product Code:** OMI
- **Device Name:** Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
- **Regulation:** [21 CFR 866.3510](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3510)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## 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).

## Classification Rationale

Class II. The special controls for this device are:

## 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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K120572](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OMI/K120572.md) | BIOPLEX 2200 TORC IGG | Bio-Rad Laboratories, Inc. | Mar 26, 2012 | SESE |
| [K080008](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OMI/K080008.md) | BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET | Bio-Rad Laboratories, Inc. | Feb 23, 2009 | SESE |

## Top Applicants

- Bio-Rad Laboratories, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OMI](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/OMI)

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