BIOPLEX 2200 EBV IGM KIT

K123021 · Bio-Rad Laboratories · LJN · Nov 2, 2012 · Microbiology

Device Facts

• Record ID: K123021
• Device Name: BIOPLEX 2200 EBV IGM KIT
• Applicant: Bio-Rad Laboratories
• Product Code: LJN · Microbiology
• Decision Date: Nov 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Indications for Use

The BioPlex® 2200 EBV IgM kit is a multiplex flow immunoassay intended for the qualitative detection of two (2) separate analytes: Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum. The test system can be used in conjunction with the BioPlex® 2200 EBV IgG kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM). The BioPlex® 2200 EBV IgM kit is intended for use with the Bio-Rad BioPlex® 2200 System. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. The BioPlex® 2200 EBV IgM Calibrator Set is intended for the calibration of the BioPlex® 2200 EBV IgM Reagent Pack. The BioPlex® 2200 EBV IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex® 2200 Instrument and BioPlex® EBV IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex® EBV IgM Control Set has not been established with any other EBV IgM antibody assays.

Device Story

The BioPlex 2200 EBV IgM kit is an automated multiplexed microparticle flow immunoassay used on the Bio-Rad BioPlex 2200 System. It utilizes dyed beads coated with EBV VCA glycoprotein and Heterophile antigens. Patient serum, diluent, and beads are incubated; anti-human IgM-phycoerythrin conjugate is added. The system detects bead identity via dye fluorescence and antibody binding via phycoerythrin fluorescence. Internal Standard, Serum Verification, and Reagent Blank beads monitor system performance. Results are expressed as an antibody index (AI). The device is used in clinical laboratories by technicians to aid in the diagnosis of infectious mononucleosis. The modification adds a protein stabilizer (goat) and protease inhibitor to the bead reagent to prevent signal depression caused by bacterial/mold contamination. This improves assay robustness, allowing for a change in QC frequency from once per pack to once per day.

Clinical Evidence

Bench testing only. Method comparison study (N=622) compared modified device to predicate, showing high agreement (PPA 98.7-100%, NPA 98.7-100%). Precision testing (CLSI EP5-A2) and interference testing (CLSI EP7-A2) confirmed performance equivalence. Contamination studies demonstrated the remediated formulation effectively resists signal loss from bacterial/mold contamination.

Technological Characteristics

Multiplexed microparticle flow cytometry immunoassay. Reagents include recombinant EBV VCA GP125/p18 and Heterophile antigen (horse erythrocyte stromal extract). Modified formulation includes goat protein stabilizer and protease inhibitor. Automated system; uses phycoerythrin-conjugated anti-human IgM. Results calculated as antibody index (AI).

Indications for Use

Indicated for qualitative detection of EBV VCA IgM and Heterophile antibodies in human serum to aid in laboratory diagnosis of infectious mononucleosis. Not for use in immunocompromised/immunosuppressed patients, neonates, infants, or for diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, or other EBV-associated lymphomas.

Regulatory Classification

Identification

Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).

Submission Summary (Full Text)

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# Decision Summary

Statement for the Record, k123021

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