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U.S. Department of Health and Human Services

Product Classification

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Device multiplex flow immunoassay, t. gondii, rubella and cmv
Regulation Description Rubella virus serological reagents.
Definition The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma. Indicated as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.
Physical State The device is a fully automated instrument.
Technical Method The device utilizes multiplex immunofluorescence technology to assess the presence of IgG antibodies for each of the analytes in the panel in a single sample by binding to antigen-coated fluoromagnetic beads with unique fluorescent signatures.
Target Area Assay
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOMI
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible