LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM

K122397 · DiaSorin, Inc. · LFX · Sep 6, 2012 · Microbiology

Device Facts

• Record ID: K122397
• Device Name: LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
• Applicant: DiaSorin, Inc.
• Product Code: LFX · Microbiology
• Decision Date: Sep 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Indications for Use

The LIAISON® Rubella IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to rubella virus in human serum samples. It is intended for use as an aid in the diagnosis of a current or recent Rubella infection in individuals with signs and symptoms of Rubella, or suspected of having rubella virus infection, including women of child bearing age. The LIAISON® Control Rubella IgM (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Rubella IgM assay. The performance characteristics of LIAISON® Rubella IgM controls have not been established for any other assays or instrument platforms.

Device Story

LIAISON® Rubella IgM is an in vitro diagnostic chemiluminescent immunoassay (CLIA) for qualitative detection of rubella-specific IgM in human serum. The device uses a Reagent Integral containing magnetic particles coated with mouse anti-human IgM, inactivated rubella viral particles, and isoluminol-conjugated mouse anti-rubella antibodies. Operation occurs on the LIAISON® Analyzer; the system performs automated incubation and wash cycles. The assay principle involves a sandwich-style binding reaction: IgM in the patient sample binds to the solid phase; rubella antigen binds to the captured IgM; and the conjugate binds to the immune complex. A flash chemiluminescence reaction is induced, and a photomultiplier measures the resulting light signal (Relative Light Units, RLU). The analyzer processes these signals to determine the presence of rubella IgM. Healthcare providers use the qualitative output to assist in diagnosing recent or current rubella infections. The device is intended for clinical laboratory use by trained personnel.

Clinical Evidence

Clinical performance was evaluated via prospective (n=448) and retrospective (n=178) studies. Prospective study showed 98.9% negative percent agreement (97.3-99.5% CI) and 60.0% positive percent agreement (30.8-83.3% CI). Retrospective study showed 98.9% positive percent agreement (96.0-99.7% CI). Analytical performance included precision studies (CLSI EP5-A2), cross-reactivity testing against 30 organisms/conditions (n=261), and interference testing (CLSI EP07-A2).

Technological Characteristics

Chemiluminescence immunoassay (CLIA) using magnetic particles and isoluminol-conjugated antibodies. Reagents include mouse monoclonal antibodies and inactivated rubella viral particles. System is a closed, automated analyzer platform. Performance validated per CLSI guidelines (EP05-A2, EP15-A2, EP07-A2).

Indications for Use

Indicated for qualitative detection of IgM antibodies to rubella virus in human serum to aid in diagnosis of current or recent rubella infection in symptomatic individuals or those suspected of infection, including women of child-bearing age.

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.

Submission Summary (Full Text)

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# Decision Summary

Statement for the Record, k122397

This 510(k) was reviewed under OIVD’s Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.

OIVD, 6/12/12, v1.2