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U.S. Department of Health and Human Services

Product Classification

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Device complement 4d (c4d) and complement receptor 1 (cr1)
Regulation Description Systemic lupus erythematosus immunological test system.
Definition The device is an indirect immunofluorescence assay utilizing monoclonal antibodies and flow cytometry in the quantitative determination of complement 4d (C4d) and complement receptor 1 (CR1) on the surface of erythrocytes from EDTA anti-coagulated whole blood. The C4d and CR1 results are used in a ratio as an aid in the diagnosis of systemic lupus erythematosus.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNRX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5820
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
Accredited Persons