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The Directigen® Meningitis Test Kits are a presumptive latex agglutination test for the direct qualitative detection of antigens to H. influenzae type b, S. pneumoniae, group B Streptococcus, N. meningitidis groups A, B, C, Y or W135 and E. coli K1 in cerebrospinal fluid (CSF), serum, urine, or blood culture media. Visible agglutination occurs when a sample containing any of these bacterial antigens is reacted with its respective antibody-coated latex beads. This 510(k) was submitted to add colony confirmation and serotyping claims to the Intended Use Statement.

Specific antibodies are bound to the surface of latex beads. In the presence of specific antigens, latex particle aggregation becomes large enough to allow visualization of positive agglutination These specific soluble polysaccharide antigens accumulate in CSF, serum, urine or blood as a result of infection by H. influenzae type b, S. pneumoniae, group B Streptococcus, N. meningitidis groups A, B, C, Y or W135 and E. coli K1.