MUREX RUB-EX

K954920 · Murex Diagnostics, Inc. · LQN · Aug 21, 1996 · Microbiology

Device Facts

• Record ID: K954920
• Device Name: MUREX RUB-EX
• Applicant: Murex Diagnostics, Inc.
• Product Code: LQN · Microbiology
• Decision Date: Aug 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Indications for Use

The Murex Rūb-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum.

Device Story

Rapid latex agglutination test; detects rubella antibodies in serum samples. Inactivated/disrupted rubella virus sensitizes latex particles. Performed in clinical laboratory settings by trained personnel. Qualitative/semi-quantitative results obtained via visual observation of agglutination. Assists clinicians in assessing rubella immune status. Reagents contain 0.1% sodium azide preservative.

Clinical Evidence

Comparative studies performed against Becton Dickinson and Orion Diagnostics test kits. No specific sensitivity, specificity, or sample size metrics provided.

Technological Characteristics

Latex agglutination assay; utilizes inactivated/disrupted rubella virus; 0.1% sodium azide preservative; manual test kit format.

Indications for Use

Indicated for qualitative and semi-quantitative detection of rubella antibodies in human serum. No specific age or gender restrictions stated.

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

• Rubascan (Becton Dickinson)
• Rubalex (Orion Diagnostics)

Submission Summary (Full Text)

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K 954920
AUG 21 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary for The Murex Rūb-ex Test

## SAFETY AND EFFECTIVENESS

The Murex Rūb-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum. The rubella virus used to sensitize the Latex Reagent is inactivated and disrupted before use. Sera used in the preparation of controls are tested with FDA approved tests for hepatitis B virus surface antigen (Hbsag) and antibodies to HIV and hepatitis C virus (HCV). Only units that are non-reactive for Hbsag and antibodies to HIV and HCV are selected. When used in accordance with the principles of Good Laboratory Practices, good standards of occupational hygiene and the instructions in the Package Insert, the reagents supplied with the test kit are not considered to present a hazard to health.

The Latex Reagent and serum controls contain 0.1% sodium azide as a preservative. Lead and copper in laboratory plumbing can react with sodium azide to produce lead and copper azide which can explode on percussion. Murex recommends that drains are flushed thoroughly with water after disposing of reagents containing sodium azide.

The Murex Rūb-ex test showed an equivalent performance in comparative studies with test kits distributed by Becton Dickinson and Orion Diagnostics. Any differences between the Murex Rūb-ex test and either Rubascan or Rubalex do not compromise the safety and efficacy of the product nor do they represent a potential unreasonable risk of illness or injury.

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